Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

Genetic Study of Clinical and Biological Predictors of Therapy-Related Leukemia

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Genetics

Closed

Children

NCI

COG-AB9804
CCG-B9804, NCT00003793, AB9804

Objectives

Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
Identify patients who are at increased risk of t-MDS/AML during or after therapy.

Entry Criteria

Disease Characteristics:

Diagnosis of sarcoma including:
- Rhabdomyosarcoma
- Ewing's sarcoma
- Primitive neuroectodermal tumor
- Fibrosarcoma
- Malignant peripheral nerve sheath tumor
- Synovial cell sarcoma
- Osteosarcoma
- Other soft tissue sarcoma

Must be currently receiving intensive or high-dose chemotherapy for sarcoma

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Patient Characteristics:

Age:

Children

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Expected Enrollment

321

A total of 321 patients will be accrued for this study within 4 years.

Outline

Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.

Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Stella Davies, MBBS, PhD, Protocol chair
Ph: 513-636-2429; 800-344-2462

Registry Information

Official Title		Clinical and Biological Predictors of Therapy-Related Leukemia

Trial Start Date		1998-12-18

Registered in ClinicalTrials.gov		NCT00003793

Date Submitted to PDQ		1998-12-16

Information Last Verified		2006-03-23

NCI Grant/Contract Number		CA98543

Note: 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.