Status:
COMPLETED
Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. An autologous stem c...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility and toxicity of haploidentical related donor lymphocyte infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft failure,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following advanced lymphoid malignancies:
- Multiple myeloma, meeting both of the following criteria:
- Deletion of chromosome 13
- Elevated pre-transplant lactic dehydrogenase
- Chronic lymphocytic leukemia (CLL)
- Failed ≥ 2 prior conventional chemotherapy regimens, including fludarabine
- Small lymphocytic lymphoma
- Follicular non-Hodgkin's lymphoma
- Received ≥ 3 prior conventional chemotherapy regimens
- Mantle cell lymphoma
- Received ≥ 3 prior conventional chemotherapy regimens
- Predicted poor outcome and relapsed disease after undergoing autologous stem cell transplantation ≥ 6 months ago
- Measurable disease, defined as any evidence of disease by scans or blood or urine analysis
- At least 8 x 10\^6 autologous CD34-positive cells/kg available for transplantation
- Stem cell mobilization allowed
- Haploidentical related donor available
- Sex-mismatched
- Identical for 1 HLA haplotype AND mismatched for ≥ 1 HLA-A, -B, -C, or DRB1 locus of the unshared haplotype
- No HLA-identical related or unrelated donor available
- Not eligible for first-line autologous stem cell transplantation on protocol FHCRC-1368.00, FHCRC-1366.00, FHCRC-1461.00, or FHCRC-1595.00
- No bulky disease, defined as total volume of all measurable tumor \> 500 cc
- No CNS disease resistant to therapy
- PATIENT CHARACTERISTICS:
- Age
- 18 to 69
- Performance status
- Karnofsky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Liver function tests or liver enzymes ≤ 2 times upper limit of normal
- Renal
- Not specified
- Cardiovascular
- Ejection fraction ≥ 45%
- No symptomatic cardiac disease
- Pulmonary
- DLCO ≥ 50%
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV Negative
- No active infection
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No concurrent contrast dye during and for 3 weeks after completion of interleukin-2 administration
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00248430
Start Date
August 1 2003
End Date
July 1 2007
Last Update
September 21 2010
Active Locations (2)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024