Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Assessing the long-term effects of therapy in patients who have been treated for childhood soft tissue sarcoma may help improve the effectiveness of follow-up programs. PURPOSE: Study to determine the long-term effects of therapy in patients who were previously treated for childhood soft tissue sarcoma.


Study summary:

OBJECTIVES: - 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. - Determine whether these patients have diminished bone mineral density. - Correlate gonadal dysfunction and metabolic stress syndrome with loss of bone mass in these patients. - Determine the quality of life of these patients. - Determine the frequency and patterns of adaptational and adjustment difficulties with distinction of clinical or subclinical psychiatric illness in these patients. - Determine myocardial tissue changes associated with anthracycline therapy and the cardiac function of patients treated with or without the cardioprotectant dexrazoxane. - Determine the incidence and frequency of secondary malignancies, hepatitis B, C, or HIV seroconversion, and ifosfamide-related renal dysfunction in these patients. - Determine the T-cell depletion following chemotherapy in these patients. 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. PROJECTED ACCRUAL: Approximately 50-100 patients will be accrued for this study within 1-2 years.


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 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 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


NCT ID:

NCT00020423


Primary Contact:

Study Chair
Patrick J. Mansky, MD
National Center for Complementary and Alternative Medicine (NCCAM)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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