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| ID | Type | Description | Link |
|---|---|---|---|
| FHCRC-1838.00 | |||
| CDR0000430694 | Registry Identifier | PDQ |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| therapeutic allogeneic lymphocytes | Biological | |||
| melphalan | Drug | |||
| bone marrow ablation with stem cell support | Procedure | |||
| peripheral blood stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | ||
| Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Extent, degree, and duration of donor chimerism | ||
| Complete response rate |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following advanced lymphoid malignancies:
Multiple myeloma, meeting both of the following criteria:
Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma
Follicular non-Hodgkin's lymphoma
Mantle cell lymphoma
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
Haploidentical related 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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| William I. Bensinger, MD | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States | ||
| Fred Hutchinson Cancer Research Center |
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| Seattle |
| Washington |
| 98109-1024 |
| United States |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D008558 | Melphalan |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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