Study of Late Effects Due to Treatment in Patients Previously Treated for Pediatric Sarcoma

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
Entry Criteria
Projected Accrual
Published Results
Trial Contact Information

Alternate Title

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

Basic Trial Information


No phase specified

Supportive care


2 and over



Special Category: NIH
Clinical Center trial


  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

    • Stable disease for more than 24 months


    • 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


Biologic therapy:

  • At least 24 months since prior immunotherapy


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

Endocrine therapy:

  • Not specified


  • At least 24 months since prior radiotherapy


  • At least 24 months since prior surgery for cancer

Patient Characteristics:


  • 2 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test

Projected Accrual

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


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.


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

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

, MD, Protocol chair
Ph: 301-435-4845
Email: 1

Trial Sites and Contacts

Grant Magnuson Clinical Center – NCI Clinical Studies Support
  Patient Recruitment

Ph:  888-NCI-1937

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