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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002787 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus GM-CSF in treating patients with multiple myeloma undergoing bone marrow or peripheral stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: keyhole limpet hemocyanin Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE I TRIAL OF POST TRANSPLANT IMMUNIZATION WITH AUTOLOGOUS MYELOMA IDIOTYPE-KLH/GM-CSF IN MYELOMA PATIENTS FOLLOWING AUTOLOGOUS OR ALLOGENEIC MARROW OR STEM CELL TRANSPLANTATION |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 1996 |
OBJECTIVES: I. Determine the safety of multiple subcutaneous vaccination with myeloma Id-KLH with adjuvant sargramostim (GM-CSF) in posttransplant myeloma patients. II. Evaluate patients' pre- and post-bone marrow transplants for evidence of endogenous idiotype specific immune response. III. Characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization. IV. Clone, expand, and characterize T cell clones specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.
OUTLINE: Patients more than 60 days posttransplant are vaccinated with autologous idiotype vaccine at 0, 2, 6, and 10 weeks. Allogeneic recipients are vaccinated after they are off corticosteroids and on a stable or tapering dose of cyclosporine or tacrolimus (FK506). A series of 4 subcutaneous injections of autologous Id-KLH is given with 3 additional daily injections of GM-CSF subcutaneously at the same site.
PROJECTED ACCRUAL: 35-40 patients will be entered.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma of late stage B cells Eligible for a FHCRC protocol using high dose therapy with syngeneic, allogeneic, or autologous marrow or stem cell transplantation Achievement of partial or greater remission for patients transplanted in relapse
PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnokfsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1000/mm3 Platelet count greater than 50,000/mm3 without transfusions or growth factors RBC supportable to hematocrit greater than 25 with less than 2 units of packed RBC/week Hepatic: Not specified Renal: Creatinine no greater than 3.0 mg/dL Other: Must have pretransplant sera available with IgG, IgA, or IgM monoclonal paraprotein with a level of 1.5 g/dL or greater identifiable on serum protein electrophoresis Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera Must be off corticosteroids prior to vaccination No infections No disease progression after transplant No graft versus host disease (GVHD) at vaccination No medical conditions that would result in inability to tolerate the vaccination No prior history of serious adverse reactions to GM-CSF
PRIOR CONCURRENT THERAPY: No concurrent posttransplant immunomodulation with IL-2
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000064851, FHCRC-1104.00, NCI-H96-0924 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002787 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Blood Protein Disorders Hematologic Diseases Physiological Effects of Drugs Adjuvants, Immunologic Vascular Diseases Paraproteinemias |
Hemostatic Disorders Keyhole-limpet hemocyanin Pharmacologic Actions Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |
