http://www.clinicaltrials.gov/ct/show/NCT00002733?order=2

Biological Therapy Plus High-Dose Cimetidine in Treating Patients
With Metastatic Cancer

Patient Abstract

Rationale

Biological therapy uses different ways to stimulate the immune system
to stop cancer cells from growing.

Purpose

Phase II trial to study the effectiveness of activated autologous
lymphocytes and high-dose cimetidine in patients with metastatic cancer
, including melanoma , sarcoma , and breast, renal cell, non-small cell
lung, colorectal, and prostate cancer.
Eligibility

    * At least 18 years old
    * Measurable disease
    * No brain metastases

Treatment

Patients' white blood cells will be collected and treated in the
laboratory with monoclonal antibody , cimetidine, and indomethacin .
Patients will receive infusions of the treated white blood cells once a
month for up to six courses. They will also receive cimetidine by mouth
four times a day throughout treatment.
Disclaimer

This abstract is intended to give a brief overview of this clinical
trial. To help determine whether the trial is appropriate for an
individual, selected major eligibility criteria are listed above. To
obtain more details related to trial eligibility and the treatment
plan, please see the Health Professional abstract of this clinical
trial. Information about ongoing clinical trials is available from the
NCI Cancer.gov Web site.

Studies

Type:

Clinical trial
Categories:

    * Treatment
          o chemotherapy
          o Non-specific immune-modulator therapy
                + cimetidine
                + indomethacin
          o Peripheral blood lymphocyte therapy

Eligibility

Ages:

18 – 120 (18 and over)
Diagnosis:

    *
      Adult soft tissue sarcoma:

      Recurrent adult soft tissue sarcoma
    *
      Adult solid tumor:

      Unspecified adult solid tumor, protocol specific
    *
      Breast cancer:

      Stage IV breast cancer
    *
      Breast cancer:

      Recurrent breast cancer
    *
      Breast cancer:

      Male breast cancer
    *
      Colon cancer:

      Stage IV colon cancer
    *
      Colon cancer:

      Recurrent colon cancer
    *
      Melanoma:

      Stage IV melanoma
    *
      Melanoma:

      Recurrent melanoma
    *
      Non-small cell lung cancer:

      Recurrent non-small cell lung cancer
    *
      Non-small cell lung cancer:

      Stage IV non-small cell lung cancer
    *
      Prostate cancer:

      Stage IV prostate cancer
    *
      Prostate cancer:

      Recurrent prostate cancer
    *
      Rectal cancer:

      Stage IV rectal cancer
    *
      Rectal cancer:

      Recurrent rectal cancer
    *
      Renal cell cancer:

      Stage IV renal cell cancer
    *
      Renal cell cancer:

      Recurrent renal cell cancer

Nayak SK, Beutel L, Irani S, et al.: Characterization of autologous
activated lymphocytes being used for adoptive immunotherapy of cancer.
[Abstract] Proc Am Assoc Cancer Res 36: A2864, 481, 1995.Dillman RO,
Nayak SK, O'Connor A, et al.: Phase I-II trial of autologous activated
lymphocytes in the treatment of metastatic cancer. J Immunother 17(2):
125, 1995.

Administrative Information
Lead Organization
Name: Cancer Biotherapy Research Group
Role: Primary
Protocol ID: CBRG-9115
Protocol chair: Robert O. Dillman, MD, FACP
Cancer Biotherapy Research Group
347-B Main Street
Franklin, Tennessee 37068-0757
Phone: 949-760-5543

This information was last updated on December 1, 1998