Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry 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	Natural history/Epidemiology	Closed	2 and over	NCI	NCI-01-C-0037C NCT00020423

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

Expected Enrollment

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.

Mansky P, Arai A, Stratton P, et al.: Treatment late effects in long-term survivors of pediatric sarcoma. Pediatr Blood Cancer 48 (2): 192-9, 2007.[PUBMED Abstract]

Wiener L, Battles H, Bernstein D, et al.: Persistent psychological distress in long-term survivors of pediatric sarcoma: the experience at a single institution. Psychooncology 15 (10): 898-910, 2006.[PUBMED Abstract]

Mansky PJ, Gerber L, Hoffman K, et al.: Rehabilitation assessments of pediatric sarcoma survivors. [Abstract] J Clin Oncol 22 (Suppl 14): A-8528, 806s, 2004.

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; 888-644-6226 Email: manskyp@mail.nih.gov

Registry Information
Official Title		Late Effects of Treatment in Survivors of Pediatric Sarcomas
Trial Start Date		2000-11-21
Registered in ClinicalTrials.gov		NCT00020423
Date Submitted to PDQ		2000-12-04
Information Last Verified		2005-12-29

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