Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
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Purpose
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 cell transplant using the patient's stem cells may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may stimulate the white blood cells to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell infusions and interleukin-2 and to see how well they work in treating patients who are undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Biological: aldesleukin Biological: therapeutic allogeneic lymphocytes Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies |
- Feasibility [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Extent, degree, and duration of donor chimerism [ Designated as safety issue: No ]
- Complete response rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2003 |
| Study Completion Date: | July 2007 |
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, and transplant-related mortality, in patients with relapsed advanced lymphoid malignancies undergoing autologous stem cell transplantation.
Secondary
- Determine the extent, degree, and duration of donor chimerism in patients treated with this regimen.
- Determine, preliminarily, activity of haploidentical DLI, as measured by complete response rate, in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous stem cell transplantation on day 0. Patients receive haploidentical related donor lymphocyte infusions (DLI) IV on days 1, 5*, and 10* and interleukin-2 (IL-2) IV continuously on days 1-12.
NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is present
After completion of study treatment, patients are followed monthly for 3 months and then every 3-12 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Principal Investigator: | William I. Bensinger, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00248430 History of Changes |
| Other Study ID Numbers: | 1838.00, FHCRC-1838.00, CDR0000430694 |
| Study First Received: | November 3, 2005 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
graft versus host disease stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma recurrent mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Immune System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Melphalan Aldesleukin Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on June 17, 2013