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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00248430
Other study ID # 1838.00
Secondary ID FHCRC-1838.00CDR
Status Completed
Phase Phase 1/Phase 2
First received November 3, 2005
Last updated September 20, 2010
Start date August 2003
Est. completion date July 2007

Study information

Verified date September 2010
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
aldesleukin

therapeutic allogeneic lymphocytes

Drug:
melphalan

Procedure:
bone marrow ablation with stem cell support

peripheral blood stem cell transplantation


Locations

Country Name City State
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility No
Primary Toxicity Yes
Secondary Extent, degree, and duration of donor chimerism No
Secondary Complete response rate No
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