DiaTech
is a private company performing patient specific cancer
chemosensitivity testing for patients and physicians. DiaTech Oncology
is doing this clinical study to see if an experimental new technology
called the Microculture Kinetic (MiCK) assay will predict treatment
outcome and can help to direct chemotherapy of cancer subjects. This
study is focused on subjects diagnosed with breast, ovarian, lung, and
colon malignancies and low-grade lymphomas. Study Objectives:

2.1 To evaluate the ability of the MiCK assay to predict the outcome
of chemotherapy of cancer patients.

2.2 To evaluate the ability of the MiCK assay to guide chemotherapy
of cancer patients.

Condition	Intervention	Phase
3.1.1 Patients With Pathological Diagnoses of Breast, Lung, and Ovarian Adenocarcinomas and Soft Tissue Sarcoma.	Drug: Chemotherapeutic Agent	Phase II Phase III

Further Study Details: 

Primary Outcomes: Study Objectives:; 2.1 To
evaluate the ability of the MiCK assay to predict the outcome of
chemotherapy of cancer patients.; 2.2 To evaluate the ability of the
MiCK assay to guide chemotherapy of cancer patients.
Expected Total Enrollment:  150

Application of the Microculture Kinetic (MiCK) Assay for Apoptosis
to Testing Drug Sensitivity of Solid Tumors DiaTech Oncology, LLC

1. 0
   Background and Rationale: Despite the use of aggressive treatment
   protocols, less than 10% of cancer patients with an advanced disease
   respond to the therapy. There is a variety of different cancer drug
   regimens, all of which have approximately the same probability of
   clinical effectiveness. Identification of those patients who will or
   will not respond to a specific chemotherapy is important for making
   decisions regarding chemotherapy regimens as well as alternative
   management approaches. A laboratory test that could help to determine
   the sensitivity of an individual patient’s tumor cells to specific
   chemotherapeutic agents would be valuable in choosing the optimal
   chemotherapy regimen for that patient with an expectation of increasing
   the response rate to the therapy. Several types of in vitro assays that
   measure tumor cell survival following exposure to cytotoxic agents have
   been evaluated for their ability to predict chemotherapy outcomes. As a
   group, these assays are referred to as drug resistance assays. In a
   resistance assay, the surviving tumor cells can be detected directly by
   their exclusion or metabolism of specific dyes. Alternatively, since
   some of tumor cells are proliferating, their survival can be detected
   by measurement of DNA synthesis by radiolabeled precursor incorporation
   or demonstration of clonogenic potential by growth into colonies in
   semi-solid culture medium. In several clinical studies, these assays
   were useful in detecting drug resistance and in predicting a poor
   prognosis for cancer patients. However, these resistance assays cannot
   detect sensitivity of an individual patient’s tumor cells to a specific
   drug. Therefore, new methods determining drug-sensitivity of the tumor
   cells of an individual patient and, thus, capable of both predicting a
   positive treatment outcome and guiding chemotherapy, would be of
   significant value.

   Recently, Dr. Kravtsov has developed an
   automated microculture kinetic (MiCK) assay for measuring drug induced
   apoptosis in tumor cells1-4. Apoptosis is a distinct mode of cell death
   which occurs under physiological conditions and yet can be induced in
   malignant cells by chemical and physical factors including antitumor
   drugs5-7. During the last decade, it has been recognized that
   chemotherapeutic agents exert their antitumor activity by triggering
   apoptosis in susceptible tumor cells8-17. This implies that the MiCK
   assay for apoptosis provides a mechanism-based approach to studying
   effects of cytotoxic agents on tumor cells. Unlike “resistance” assays
   that measure a fraction of cells surviving drug exposure, the MiCK
   assay measures a fraction of tumor cells killed by a chemotherapeutic
   agent via mechanism of apoptosis. Therefore the MiCK assay determines
   drug sensitivity, rather than resistance. Recently the MiCK assay has
   been shown to predict complete remission rate and survival in acute
   myeloid leukemia patients better than clinical criteria did18-20. In a
   limited study, the MiCK assay has been used to direct chemotherapy of
   the leukemia patients 21.

   The MiCK assay has also been used to study
   drug-induced apoptosis in solid tumors, including neuroblastoma and
   colon adenocarcinoma cell lines22-23. More recent data accumulated by
   DiaTech has demonstrated that the MiCK assay can detect drug induced
   apoptosis in primary cultures of tumor cells isolated from patients
   with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and
   high grade soft tissue sarcoma. Based on these data, we suggest that
   the MiCK assay may be used to detect drug sensitivity profiles of
   individual patients with various types of solid tumors. This, in turn,
   may provide a way to tailor chemotherapy to an individual patient’s
   drug sensitivity profile, and, thus, improve treatment outcomes,
   decrease adverse effects of the chemotherapy, increase the quality of
   patient’s life, and reduce the treatment cost.

   2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK
   assay to predict the outcome of chemotherapy of cancer patients.

   2.2 To evaluate the ability of the MiCK assay to guide
   chemotherapy of cancer patients.

   3.0 Patient Population:

   3.1 Inclusion criteria: 3.1.1 Patients with pathological
   diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue
   sarcoma.

   3.1.2 Patients with de novo malignancies and no previous
   chemotherapy 3.1.3 Patients with advanced refractory malignancies who
   received no more than 2 standard chemotherapy treatment protocols.

   3.1.4 Patients of any age group. 3.1.5 Patients must have tumor
   which is accessible and agree to undergo biopsies, or drainage of
   effusions.

   3.1.6
   Patients for whom chemotherapy is a treatment option. 3.2 Explanations:
   We anticipate that newly diagnosed patients will be mostly used to
   evaluate the ability of the MiCK assay to predict the outcome of the
   chemotherapy (Objective #2.1) and to establish criteria correlating
   numerical response in the MiCK assay with probability of the clinically
   established complete remission. The patients with refractory
   malignancies will be mostly used to evaluate the ability of the MiCK
   assay to guide cancer chemotherapy (Objective #2.2). Patients will be
   seen and managed as outpatients or inpatients, depending on a clinical
   standard of the institution.

   3.3 Exclusion criteria: 3.3.1 Patients with
   symptomatic/uncontrolled parenchymal brain metastasis and not
   accessible tumors.

   3.3.2
   Patients with meningeal metastasis. 3.3.3 Patients for whom
   chemotherapy clinically is not indicated. 3.3.4 Pregnancy. During the
   course of the study, all patients of childbearing potential should be
   instructed to contact the treating physician if they suspect they might
   have conceived a child; for females, a missing or late menstrual period
   should be reported to the treating physician. If pregnancy is confirmed
   by a pregnancy test, the patient must not receive study medication and
   must not be enrolled into the study or, if already enrolled, must be
   withdrawn from the study. If a male patient is suspected of having
   fathered a child while on the study drugs, the pregnant female partner
   must be notified and counseled regarding the risk to the fetus.
   Pregnancy during the course of this study will be reported to the
   Principal Investigator as a serious adverse event. Women of child
   bearing potential are defined to include any female who has experienced
   menarche and has not undergone successful surgical sterilization
   (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or
   is not post-menopausal (defined as amenorrhea for more than 12
   consecutive months); these includes also females using oral, implanted,
   or injectable contraceptive hormones, mechanical devices, or barrier
   methods to prevent pregnancy.

   4.0 Treatment Plan: 4.1 For the patients
   involved under the Study Objective (2.1), treatment protocol for an
   individual will not be influenced by the results of the MiCK assay for
   that patient. Oncologists will be blinded of the results of the MiCK
   assay and the patients will be treated according to a standard
   treatment protocol. When available, actual clinical response to the
   treatment will be compared with that predicted by the MiCK assay.

   4.2 For the patients involved under the
   Study Objective (2.2), treatment protocol for an individual patient
   will be designed based on the results of the MiCK assay for that
   patient. The drug with the best activity in the assay will be used to
   treat the individual patients. If more than one drug is equally active,
   the patient will receive the active drug in a class he/she has not
   received before. If no drug is found to have activity (insensitivity in
   the assay), the patients will be treated on an empiric basis with a
   class of drug he/she never received in the past.

   5.0 Definition of Clinical Response 5.1 All patients will be
   evaluated for clinical response to chemotherapy as per standard
   protocol established for a specific malignancy.

   5.1.1 Complete Remission is defined as total disappearance of
   clinically and radio logically detectable disease for at least four
   weeks.

   5.1.2
   Partial Response is defined as at least 50% reduction of all measurable
   tumor lesions as measured by the sum of products of the perpendicular
   diameters of the greatest dimensions of measurable lesions, with no new
   lesions appearing for at least four weeks.

   5.1.3 Stable Disease is defined as a reduction by less than 50%
   or increase by less than 25% in the size of the tumor lesions, with no
   new lesions appearing.

   5.1.4 Progressive Disease is defined as appearance of any new
   tumor lesions or increase of 25% or more in the sum of products of the
   perpendicular diameters of the greatest dimensions of measurable
   existing lesions.

   6.0
   Definition of the drug response in the MiCK assay. 6.1 In the MiCK
   assay, the extent of drug-induced apoptosis is measured in Kinetic
   Units (KU) on a scale from 0 to 16 (Blood, 1998). Apoptotic responses
   in KU will be calculated for each dose of a tested drug or drug
   combination. The maximal numerical response induced by a drug will be
   considered the “best apoptotic response” to the drug.

   6.1.1 Under the Study Objective (2.1), the
   “best apoptotic response” to the drug will be compared to the clinical
   response to the drug to establish a numerical value of the in vitro
   response discriminating drug-sensitive and drug-insensitive tumors
   (establishing a numerical cut-off of sensitivity). From our experience
   with establishing cut-off values of drug sensitivity for acute
   leukemia, 25-30 patients should provide a sufficient statistical power
   for getting a significant discriminator. These 25-30 patients will be
   fed from both patients participating under Study Objective (2.1) and
   Study Objective (2.2). After the numerical cut-off for sensitivity is
   established, it will be applied to a cohort of patients who received
   treatment with the drug to compare responses predicted in the MiCK
   assay to the actual clinical responses. This second part of the study
   will have two legs: (a) “prospective” (using 30-35 patients entering
   the study after establishing the discriminator, and (b) “retrospective”
   (using an available database of the patients who received treatment in
   the past and who’s clinical response to the chemotherapy is known).

   6.1.2 For the patients participating under
   the Study Objective (2.2), a drug inducing the highest “best apoptotic
   response” will be considered the best active drug and will be
   recommended for including in the treatment protocol. Only drugs with
   the numerical value of the “best apoptotic response” exceeding a
   certain threshold should be expected to induce a complete remission. In
   the beginning of the study, such a threshold will be judged based on
   the results of the previous leukemia study19-22. As first 25-30
   patients enter the study, the thresholds will be established for solid
   tumor patients as described in (6.1.1) and used thereafter. Considering
   that these 25-30 patients will be fed from both patients participating
   under Study Objective (2.1) and Study Objective (2.2), we expect to
   have first statistical correlations available no later than 3-4 months
   after the study begins.

   6.1.3 Drug selection for testing against
   tumor cells will be based on the previous chemotherapy history of an
   individual patient with consideration of the future treatment plans.
   The drugs will be selected from a compendium of agents recommended for
   the treatment of the patient’s malignancy.

   7.0 Statistics 7.1 We estimate that
   sufficient statistical power will be obtained with approximately 50-60
   patients with successful MiCK assays. A successful MiCK assay is
   defined as an assay for which a sufficient number of viable tumor cells
   could be isolated from the submitted pathologic material. For
   correlations between the patient’s sensitivity profiling in the MiCK
   assay and clinical responses, the patients will be evaluated as the
   whole group as well as stratified based on the type of malignancy. The
   latter will depend on the number of patients with specific tumor types
   available for the study.

   7.2 In order to discriminate between the
   drug-sensitive and drug insensitive tumor cell populations, the best
   responses to each agent will be compared in a receiver operator
   characteristic (ROC) analysis as well as logistic regression analysis
   with attainment of CR (CR vs No CR). Based on the best combination of
   statistical sensitivity, specificity, and p value, thresholds
   demarcating drug sensitivity and insensitivity will be established. The
   Fisher’s exact test, chi-square test and analysis of variance method
   will be employed to test the correlation between the clinical response
   results and other clinical variables. For lifetime data analyses,
   Kaplan-Meier estimates of survival will be used. Other statistical
   techniques may also be implied if found useful.

   8.0 Specimen collection, purification of tumor cells and
   sensitivity testing 8.1 Specimen collection must be performed as per
   related DiaTech Standard Operating Procedures (SOP).

   8.1.1
   Collection of a Solid Tumor Biopsy Specimen is performed under sterile
   conditions, using excision biopsy technique, to obtain at least 2 cm3
   of viable tumor tissue. The more viable tumor tissue is submitted for
   the study, the more chemotherapeutic agents can be tested against the
   tumor cells. Effusion specimen (peritoneal fluid, pleural fluid and
   effusions from other anatomical sites) should be collected in a
   commercial sterile container/bag with added Sodium Heparin (10 U/ml) to
   prevent clotting. The sample size should not be less than 500 ml. The
   specimen should not be fixed, or frozen.

   8.1.2 Transportation: seal the transport
   tube/container/bag tightly. Label specimen with institution, patient
   name, date and time of collection, and anatomical site of collection.
   Place the transport tube/container/bag on ice pack (blue ice). Ice pack
   must be frozen before placing it to the container. Fill out the Study
   Requisition form and include with the transportation container.

   8.1.3 Place the 50 mL tubes or a container
   inside the zip-lock bag and seal. Place specimen and Cold Pak (blue
   ice) in a transport box. Place completed patient information forms and
   specimen transport box into FedEx plastic “Diagnostic Specimen
   Envelope” and seal. Complete and affix the FedEx Airbill to the outside
   of the Diagnostic Specimen Envelope. Be sure that the airbill is marked
   “FedEx Priority Overnight” delivery. Put $5 value on the FedEx Airbill.
   Indicate “Human tissue for diagnostic studies” in the appropriate
   section of the FedEx Airbill. Call DiaTech Oncology at (514)-398-5174
   (Steve Moisan, lab manager) or (514)-398-5154 (general lab) with the
   Fed Ex Tracking Number. DiaTech must receive the specimen within 24
   hours of collection. Specimens sent on Friday must be marked for
   Saturday delivery.

   8.2 Tumor cell purification and their chemosensitivity testing
   will be performed as per related DiaTech SOPs.

   8.2.1
   Tissue biopsy and effusion specimens will be treated to obtain a
   suspension containing single tumor cells and/or small cell aggregates
   composed of 2-20 tumor cells. Using gradient centrifugation, red blood
   cell lysing, cell strainers, magnetic beads and other appropriate
   techniques, the tumor cell suspension will be enriched to at least 80%
   purity and no less than 90% viability. Immunocytochemical stains or,
   when applicable, flow cytometry will be used to confirm the presence of
   specific tumor markers on purified cells After purification, selected
   chemotherapeutic agents will be tested against purified tumor cells in
   the MiCK assay.

   8.2.2 The purified tumor cells will be
   suspended in culture medium and plated in 96-well microtiter plates.
   Multiple concentrations of chemotherapeutic agents will be achieved by
   adding each respective agent to wells in 5 μL aliquots The ranges of
   final drug concentrations will be based on reports of pharmacokinetic
   studies of the drugs and their active metabolites in patients. Data
   processing and quantification of drug-induced apoptosis will be
   performed by a proprietary ProApoTestTM software. The extent of
   apoptosis will be determined and expressed as kinetic units (KU) of
   apoptosis.

   9.0 Efficacy measurement 9.1 For patients
   participating under Study Objective (2.1), the goal of the study is to
   establish a statistically significant discriminator of sensitivity
   which would correlate with the rate of CR. Such discriminator should be
   applicable to patient’s populations participating under Study
   Objectives (2.1) and (2.2).

   9.2 For patients participating under Study
   Objective (2.2), we would expect no greater than a 10% response rate in
   refractory solid tumor patients to any standard chemotherapy. A
   response rate to the MiCK assay-guided therapy of less than 10% would
   be of no further interest. A response rate of 10-30% will suggest the
   MICK assay needs further study. A response rate greater than 30% would
   justify usefulness of the MiCK assay in guiding chemotherapy of
   patients with refractory solid tumors.

   10.0 Specimen’s left over 10.1 If a
   specimen contains more tumor cells than needed for testing their
   sensitivity to the drugs specified by the patient’s oncologist, an
   excess of the tumor cells may be considered for use for other research
   studies conducted by DiaTech Oncology. Patients will be asked for their
   permission to use specimen’s left over for research purposes by signing
   the following release included in the requisition form: “You are
   participating in the Research Program which may result in improvements
   of the treatment outcome for cancer patients. There is no direct
   benefit for you at present time. Your physician is submitting to
   DiaTech a specimen containing your tumor cells. At DiaTech, we purify
   the tumor cells, count them, check their viability, and store them in
   the DiaTech Tissue Bank. All these procedures are performed at no cost
   to you or your family. Your cells may be used for the chemosensitivity
   testing for research purposes or in other studies. Results of the
   research may be published, or used commercially in the area of new
   anti-cancer drug or treatment protocol development. To assure your
   privacy, should the results of the studies be published, you will be
   referred to only by number. Your signature below indicates that you
   agree to these terms”.

   If a patient refuses to sign the above
   release, the specimen’s left over will be decontaminated using 10%
   formaldehyde for 24h and discarded as per related SOP. If a patient
   grants his/her permission for use on the specimen’s left over in a
   future research, an excess of the tumor cells will be frozen and stored
   in liquid nitrogen indefinitely.

   10.2 Specimen’s left over may be used to
   study anti-tumor effects of chemotherapeutic drugs or drug
   combinations, to study mechanisms of drug resistance, to correlate
   phenotypic features of the tumor cells with their drug sensitivity
   profile.

   11.0 Plan of communication between Principal Investigator and
   co-Principal Investigator.

   To
   insure proper communication between Vladimir Kravtsov, MD, the Study
   Principal Investigator, and participating co-Principal Investigator the
   following communication means will be used: FedEx delivery of the
   printed materials, Phone & Fax, E-mail, Video-conferencing

   11.1 At the time of submission of the
   patient’s specimen for the study, relevant clinical information will be
   submitted to DiaTech in the form of a study requisition form prepared
   by the participating co-PI (or designated staff nurse) using FedEx
   courier service.

   11.2 Upon receiving the specimen and requisition form and after
   purification of tumor cells from the specimen, Dr. Kravtsov will place
   a telephone call to the referring oncologist (co-PI) to discuss the
   case.

   11.3
   Upon completion of the patient’s tumor drug sensitivity testing,
   results will be scored and introduced to the study data base. Dr.
   Kravtsov will issue a study report and it will be faxed to the
   referring oncologist no later than 96h after receiving the specimen.
   After faxing the report, Dr. Kravtsov will call the referring
   oncologist to discuss the results.

   11.4 After each 2 cycles of therapy, the
   patient’s treatment response will be evaluated by the referring
   oncologists (co-PI). A study Response Evaluation Form (see attached)
   will be filled out and faxed to DiaTech to be included in the study
   data base.

   11.5 After data from first ten consecutive patients are
   collected, a telephone or video conference will be scheduled between
   Dr. Kravtsov and the co-PI to summarize to discuss the preliminary
   results.

   11.6
   After data from first 30 consecutive patients are collected, an interim
   statistical analysis will be performed and Dr. Kravtsov will visit the
   participating hospital to present and discuss the results with the
   co-Principal investigator.

   11.7 At the end of the first year, statistical analysis of the
   accumulated data will be performed and all participating co-PIs will be
   invited to a conference (place to be determined) to discuss the
   results.

   11.8 DiaTech Study coordinator (Mr. Garry Latimer) will contact
   each site co-PI or a designated nurse monthly to assure proper supply
   of transportation containers and to address administrative issues.

   11.9 All communication between the study coordinator and the
   participating oncology practice will be documented, reported to the
   Principal Investigator, and discussed with the co-Principal
   Investigator.

   APPENDIX A

   TREATMENT PLAN ALGORITHM FOR STUDY OBJECTIVE 2.1

   Study Objective 2.1: To evaluate the ability of the MiCK assay
   to predict the outcome of chemotherapy of patients with solid tumors
   for first- and second-line treatments.

   Chemotherapeutic agent(s) to be included in the treatment
   protocol are selected by a medical oncologist based on published
   standards and treatment guidelines.

   Chemotherapy of the patient is initiated as per clinical
   treatment protocol and the oncologist discretion.

   Name(s) of the drug(s) selected for the treatment is provided to
   the DiaTech lab along with the tumor material obtained from the
   patient.

   Tumor cells purified from the patient’s specimen are tested for
   their sensitivity to the drugs selected for the patient’s treatment.

   Results of the drug sensitivity testing are scored and
   introduced to the study database.

   After each cycle of therapy, the patient is evaluated for the
   response to the treatment as per established criteria (clinical exam,
   CT, tumor markers).

   Actual treatment response to the drug is compared with the drug
   scoring in the in vitro drug sensitivity test.

   APPENDIX B

   TREATMENT PLAN ALGORITHM FOR STUDY OBJECTIVE 2.2

   Study
   objective 2.2: To evaluate the ability of the MiCK assay to guide
   chemotherapy of cancer patients in a third line, refractory treatment
   setting.

   Chemotherapeutic agents available for the treatment are
   identified by a medical oncologist based on published standards and
   treatment guidelines.

   Names of the drugs are provided to the DiaTech lab along with
   the tumor material obtained from the patient.

   Tumor
   cells purified from the patient’s specimen are tested for their
   sensitivity to the drugs selected by the patient’s oncologist.

   Results of the drug sensitivity testing are scored, introduced
   to the study database, and reported to the medical oncologist.

   The drug with the best anti-tumor activity in the assay is used
   to treat the patient.

   After each cycle of therapy, the patient is evaluated for the
   response to the treatment as per established criteria (clinical exam,
   CT, tumor markers).

Ages Eligible for
Study:  18 Years   –   85 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:3.1 Inclusion criteria:

3.1.1 Patients with pathological diagnoses of breast, lung, and
ovarian adenocarcinomas and soft tissue sarcoma.

3.1.2 Patients with de novo malignancies and no previous
chemotherapy 3.1.3 Patients with advanced refractory malignancies who
received no more than 2 standard chemotherapy treatment protocols.

3.1.4 Patients of any age group. 3.1.5 Patients must have tumor
which is accessible and agree to undergo biopsies, or drainage of
effusions.

3.1.6 Patients for whom chemotherapy is a treatment option.

Exclusion Criteria:

3.3 Exclusion criteria: 3.3.1 Patients with symptomatic/uncontrolled
parenchymal brain metastasis and not accessible tumors.

3.3.2
Patients with meningeal metastasis. 3.3.3 Patients for whom
chemotherapy clinically is not indicated. 3.3.4 Pregnancy. During the
course of the study, all patients of childbearing potential should be
instructed to contact the treating physician if they suspect they might
have conceived a child; for females, a missing or late menstrual period
should be reported to the treating physician. If pregnancy is confirmed
by a pregnancy test, the patient must not receive study medication and
must not be enrolled into the study or, if already enrolled, must be
withdrawn from the study. If a male patient is suspected of having
fathered a child while on the study drugs, the pregnant female partner
must be notified and counseled regarding the risk to the fetus.
Pregnancy during the course of this study will be reported to the
Principal Investigator as a serious adverse event. Women of child
bearing potential are defined to include any female who has experienced
menarche and has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or
is not post-menopausal (defined as amenorrhea for more than 12
consecutive months); these includes also females using oral, implanted,
or injectable contraceptive hormones, mechanical devices, or barrier
methods to prevent pregnancy.

Please refer to this study by ClinicalTrials.gov
identifier  NCT00243685

Tennessee
      Clarksville Regional Hematology/Oncology Group, Clarksville, 
Tennessee,  37043,  United States; Recruiting

      Nashville Breast Center, Nashville,  Tennessee,  37203,  United
States; Recruiting

Texas
      Cancer Care Centers of South Texas, San Antonio,  Texas,  78229, 
United States; Recruiting

Study chairs or principal investigators

Vladimir D Kravtsov, MD PhD,  Principal Investigator,  Medical Director
DiaTech Oncology   
Pat Whitworth, MD,  Principal Investigator,  Director, Nashville Breast
Center, PC   
Thomas W Butler, MD,  Principal Investigator,  Clarksville Regional
Hematology/Oncology Group   
Alexander Zweibach, MD PhD,  Principal Investigator,  Cancer Care
Centers of South Texas   

Study ID Numbers:  20050113
Last Updated:  December 9, 2005
Record first received:  October 20, 2005
ClinicalTrials.gov Identifier:  NCT00243685
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this
record on 2005-12-30