http://www.nci.nih.gov/clinical_trials/view_clinicaltrials.aspx?cdrid=68407&version=healthprofessional

Study of Late Effects Due to Treatment in Patients Previously Treated for
Pediatric Sarcoma
Last Modified: 12/10/2002     First Published: 2/1/2001  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Published Results
Trial Contact Information

Alternate Title

Long-Term Effects of Therapy in Patients Previously Treated for Childhood
Soft Tissue Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Active 2 and over NCI NCI-01-C-0037C

Special Category: NIH
Clinical Center trial

Objectives

1. Determine the incidence and degree of functional
   musculoskeletal impairment, late cardiac dysfunction induced by doxorubicin,
   gonadal dysfunction induced by alkylator-based chemotherapy and/or radiotherapy,
   and metabolic stress syndrome induced by dose-intensive chemotherapy in patients
   previously treated for pediatric sarcoma.
2. Determine whether these patients have diminished
   bone mineral density.
3. Correlate gonadal dysfunction and metabolic stress
   syndrome with loss of bone mass in these patients.
4. Determine the quality of life of these patients.
5. Determine the frequency and patterns of adaptational
   and adjustment difficulties with distinction of clinical or subclinical psychiatric
   illness in these patients.
6. Determine myocardial tissue changes associated
   with anthracycline therapy and the cardiac function of patients treated with
   or without the cardioprotectant dexrazoxane.
7. Determine the incidence and frequency of secondary
   malignancies, hepatitis B, C, or HIV seroconversion, and ifosfamide-related
   renal dysfunction in these patients.
8. Determine the T-cell depletion following chemotherapy
   in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of sarcoma in first remission or continued
  remission of more than 5 years after completion of salvage therapy for disease
  relapse
  • Stable disease for more than 24 months

    OR

  • No evidence of disease
• Prior enrollment on a National Cancer Institute
  Pediatric Oncology Branch (POB) protocol or the Natural History protocol
  and treated according to POB outlines for sarcomas
• Received prior chemotherapy according to prior
  POB trial

Prior/Concurrent
Therapy:

Biologic therapy:

• At least 24 months since prior immunotherapy

Chemotherapy:

• See Disease Characteristics
• At least 24 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 24 months since prior radiotherapy

Surgery:

• At least 24 months since prior surgery for cancer

Patient Characteristics:

Age:

• 2 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• Negative pregnancy test

Projected Accrual

Approximately 50-100 patients will be accrued for this study
within 1-2 years.

Outline

Patients undergo evaluation of the following: cardiac dysfunction
by echocardiogram, MUGA scan, and cardiac MRI with gadolinium texaphyrin
contrast; gonadal dysfunction by physical examination, endocrine testing,
and semen analysis; hormonal stress by serum hormone levels; musculoskeletal
impairment by bone densitometry and musculoskeletal and functional testing
by rehabilitation medicine specialists; transfusion-associated risks by
hepatitis A, B, C, HIV, and HTLV-1 testing; and other major organ impairments.

Quality of life and psychosocial effects (including post-traumatic
stress syndrome) are also assessed.

Disclaimer

The purpose of most clinical trials listed
in this database is to test new cancer treatments, or new methods of diagnosing,
screening, or preventing cancer. Because all potentially harmful side effects
are not known before a trial is conducted, dose and schedule modifications
may be required for participants if they develop side effects from the treatment
or test. The therapy or test described in this clinical trial is intended
for use by clinical oncologists in carefully structured settings, and may
not prove to be more effective than standard treatment. A responsible investigator
associated with this clinical trial should be consulted before using this
protocol.

Published Results

Mansky PJ, Hoffman K, Derdak J, et al.: Preserved functionality and increased
cardiovascular disease risk in pediatric sarcoma long-term survivors. [Abstract]
Proceedings of the American Society of Clinical Oncology 22: A-3261, 2003.

Mansky PJ, Lawande N, Long L, et al.: MRI evidence for cardiac remodeling
in longterm pediatric sarcoma survivors of doxorubicin therapy. [Abstract]
Proceedings of the American Society of Clinical Oncology 21: A-1559, 2002.

Wiener L, Battles H, Long L, et al.: Persistent psychological distress
in long-term survivors of pediatric sarcoma. [Abstract] Proceedings of the
American Society of Clinical Oncology 21: A-2912, 2002.

Trial Contact Information

Trial Lead Organizations

NCI – Center for Cancer Research

Patrick Mansky, MD, Protocol chair		Ph: 301-435-4845 Email: manskyp@mail.nih.gov 1

Trial Sites and Contacts

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center – NCI Clinical Studies Support
		Patient Recruitment	Ph:  888-NCI-1937

Table of Links

1	manskyp@mail.nih.gov