Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia.
-
Determine the dose effect of autologous PBSC on engraftment in this patient population.
OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells.
Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation.
Patients are followed at 100 days, 6 months, and 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of acute lymphoblastic leukemia
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Pathologic evidence of relapse in marrow, CNS, or testes
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In second or later complete remission
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Ineligible for allogeneic transplantation:
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No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR
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Ineligible for preparative regimen including total-body irradiation
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Peripheral blood stem cell collection feasible:
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Patient size generally at least 8 kg
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Able to place central venous catheter
-
Patient cooperative
PATIENT CHARACTERISTICS:
Age:
- 1 to 19
Performance status:
- Not moribund
Life expectancy:
- No severe limits from disease other than leukemia
Hepatic:
-
Bilirubin no greater than 3 times normal for age
-
AST and/or GGT no greater than 3 times normal for age
-
No evidence of hepatic synthetic dysfunction
Renal:
- GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance
Cardiovascular:
- Cardiac contractility normal on echocardiogram
Pulmonary:
- FVC and FEV_1 with or without DLCO at least 50% predicted
Other:
-
No significant active infection
-
HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-3330 |
Sponsors and Collaborators
- University of Nebraska
Investigators
- Study Chair: Bruce G. Gordon, MD, University of Nebraska
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UNMC-06695
- CDR0000064114
- NCI-V95-0639