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

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020423

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.

Condition	Intervention
Cancer-Related Problem/Condition Sarcoma	Procedure: fertility assessment and management Procedure: management of therapy complications Procedure: metabolic abnormality assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Infertility Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Observational
Official Title:	Late Effects of Treatment in Survivors of Pediatric Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2000

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020423

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Patrick J. Mansky, MD

National Center for Complementary and Alternative Medicine (NCCAM)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Mansky P, Arai A, Stratton P, Bernstein D, Long L, Reynolds J, Chen D, Steinberg SM, Lavende N, Hoffman K, Nathan PC, Parks R, Augustine E, Chaudhry U, Derdak J, Wiener L, Gerber L, Mackall C. Treatment late effects in long-term survivors of pediatric sarcoma. Pediatr Blood Cancer. 2007 Feb;48(2):192-9.

Wiener L, Battles H, Bernstein D, Long L, Derdak J, Mackall CL, Mansky PJ. Persistent psychological distress in long-term survivors of pediatric sarcoma: the experience at a single institution. Psychooncology. 2006 Oct;15(10):898-910.

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.

Study ID Numbers:	CDR0000068407, NCI-01-C-0037C
Study First Received:	July 11, 2001
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00020423
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized osteosarcoma
metastatic osteosarcoma
nonmetastatic childhood soft tissue sarcoma
metastatic childhood soft tissue sarcoma
cardiac toxicity
long-term effects secondary to cancer therapy in children
psychosocial effects/treatment
sexual dysfunction and infertility

osteoporosis
quality of life
previously treated childhood rhabdomyosarcoma
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
childhood synovial sarcoma

Study placed in the following topic categories:

Infertility
Neuroectodermal Tumors, Primitive
Synovial sarcoma
Ewing's family of tumors
Malignant mesenchymal tumor
Quality of Life
Osteosarcoma
Osteoporosis
Osteogenic sarcoma
Soft tissue sarcomas
Sarcoma, Synovial
Neuroectodermal Tumors

Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Peripheral neuroectodermal tumor
Neoplasms, Germ Cell and Embryonal
Sarcoma
Neoplasm Metastasis
Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial
Rhabdomyosarcoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009