Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00248430

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	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

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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

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

Study Start Date :

Aug 1, 2003

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Feasibility []
Toxicity []

Secondary Outcome Measures

Extent, degree, and duration of donor chimerism []
Complete response rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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