NCT00248430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

November 3, 2005

Last Update Submit

September 20, 2010

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

graft versus host diseasestage II multiple myelomastage III multiple myelomarefractory multiple myelomarefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (2)

  • Feasibility

  • Toxicity

Secondary Outcomes (2)

  • Extent, degree, and duration of donor chimerism

  • Complete response rate

Interventions

aldesleukinBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
melphalanDRUG
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-CellLymphoma, Follicular

Interventions

aldesleukinMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • William I. Bensinger, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

August 1, 2003

Study Completion

July 1, 2007

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(2)