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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024466 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Biological: autologous tumor cell vaccine Drug: chemotherapy Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once. Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Study Chair: | Ivan Borrello, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068953, JHOC-J0115, JHOC-01011706, JHOC-K0007, NCI-G01-2020 |
Study First Received: | September 13, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00024466 History of Changes |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |