Status:
COMPLETED
Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 40 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the...
Detailed Description
OBJECTIVES: * Evaluate disease-free and overall survival of patients with high-risk tumors of the Ewing's family treated with unmodified T-cell depleted allogeneic hematopoietic stem cell transplanta...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of high-risk tumors of the Ewing's family as defined by 1 of the following:
- Biopsy-proven disease with distant metastases to sites other than the lung
- Relapsed disease after completion of prior standard front-line therapy or high-dose chemotherapy
- Currently in complete remission (CR) with no evidence of disease (with or without minimal residual disease) or very good partial remission (i.e., CR with an abnormal bone scan) after prior standard or high-dose chemotherapy with local control
- HLA-compatible stem cell donor available
- Compatible donors include those matched at both HLA-A, -B, -C, -DR and 1 of 2 -DQ alleles by high-resolution molecular typing
- Related or unrelated donor
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 70-100% (≥ 16 years old) OR Lansky PS 70-100% (\< 16 years old)
- LVEF \> 50% at rest
- SGOT \< 3 times upper limit of normal
- Bilirubin \< 2.0 mg/dL (unless liver is involved with disease)
- Creatinine normal AND/OR creatinine clearance \> 60 mL/min
- Lung diffusion capacity \> 50% of predicted (corrected for hemoglobin) OR asymptomatic with a room air oxygen saturation of ≥ 98%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled viral, bacterial, or fungal infection
- No HIV-1 or -2 positivity
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy with 100 mg/m² of melphalan
- No prior high-dose chemotherapy requiring autologous stem cell rescue
- No prior radiotherapy to \> 50% of the pelvic marrow space
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00357396
Start Date
June 1 2005
End Date
October 1 2009
Last Update
November 25 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065