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Sponsored by: |
Mayo Clinic |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00616720 |
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: aldesleukin Drug: idiotype-pulsed autologous dendritic cell vaccine APC8020 Drug: recombinant interferon gamma Procedure: flow cytometry Procedure: laboratory biomarker analysis Procedure: polymerase chain reaction Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma |
Estimated Enrollment: | 15 |
Study Start Date: | August 2001 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment (post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are randomized to 1 of 2 arms.
In both arms, patients undergo apheresis for collection of peripheral blood mononuclear cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by loading DC with immunoglobulin idiotype prepared from the patient's serum.
In both arms, treatment continues in the absence of disease progression.
Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype protein; and CTL and T-helper response by flow cytometry.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
Serum M protein < 1 g/dL, and 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000582566, MAYO-998003 |
Study First Received: | February 14, 2008 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00616720 |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Immunoglobulin Idiotypes Interferon Type II Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Interferons Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Aldesleukin Multiple myeloma Lymphoproliferative Disorders Interferon-gamma, Recombinant Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Cardiovascular Diseases Antiviral Agents Pharmacologic Actions |