Chemotherapy, Radiation Therapy, Peripheral Stem Cell Transplantation, and Immunosuppressive Therapy in Treating Patients With Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Immunosuppressive drugs such as mycophenolate mofetil and cyclosporine may be an effective treatment to prevent rejection.
PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy, radiation therapy, and peripheral stem cell transplantation followed by immunosuppressive therapy in treating patients who have cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: therapeutic allogeneic lymphocytes Drug: chemotherapy Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil |
| Study Start Date: | May 2000 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the risk of graft rejection associated with the addition of fludarabine to a nonmyeloablative conditioning regimen in patients with malignancies treatable by allogeneic bone marrow (stem cell) transplantation. II. Compare the rate of graft rejection in patients treated with this regimen vs patients previously untreated with fludarabine. III. Determine the rate of acute grade II/IV graft versus host disease (GVHD) and chronic GVHD in these patients treated with fludarabine, low dose total body irradiation, and allogeneic peripheral blood stem cell transplantation followed by immunosuppression with cyclosporine and mycophenolate mofetil.
OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -4 to -2, and total body irradiation followed by filgrastim (G-CSF) mobilized allogeneic peripheral blood stem cell transplantation on day 0. Patients also receive oral cyclosporine twice daily on days -3 to 56 and oral mycophenolate mofetil twice daily on days 0 to 27. Following completion of immunosuppression therapy patients with stable mixed chimerism and no evidence of graft versus host disease (GVHD) receive donor lymphocytes IV over 30 minutes on or after day 65. Treatment repeats every 65 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed weekly until day 90 after last lymphocyte infusion, at 4, 6, 12, 18, and 24 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: 50 to 74 years old and diagnosed with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), or multiple myeloma Not eligible for curative autologous transplantation or failed prior autologous transplantation NHL and CLL patients must have failed prior therapy with an alkylating agent and/or fludarabine or be at high risk for relapse Multiple myeloma patients must have stage II or III disease and received prior chemotherapy OR Under 50 years old and diagnosed with NHL, CLL, or multiple myeloma Not eligible for curative autologous transplantation At high risk for regimen related toxicity due to prior autologous transplantation or preexisting medical condition OR Under 75 years old and diagnosed with other malignant disease treatable by allogeneic bone marrow transplantation Not eligible for curative autologous transplantation At high risk for toxicity related to standard high dose regimens due to a preexisting chronic disease affecting kidneys, liver, lungs, and heart Includes the following likely diseases: Myelodysplastic syndrome Myeloproliferative syndromes Acute leukemia with less than 10% blasts Amyloidosis Hodgkin's disease Renal cell carcinoma OR Other malignancies for which patient has declined standard allografts No rapidly progressive aggressive NHL unless in minimal disease state No active CNS involvement Must have HLA genotypically or phenotypically identical related donor meeting these criteria: 12 to 74 years old (pediatric donors will provide bone marrow) No identical twin Not pregnant HIV negative No known allergy to filgrastim (G-CSF) No concurrent serious systemic illness Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 75 Menopausal status: Not specified Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGPT and SGOT under 4 times ULN Renal: Renal failure allowed Cardiovascular: Cardiac ejection fraction at least 40% No poorly controlled hypertension Pulmonary: No severe defects in pulmonary function No supplementary continuous oxygen Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 1 year following study HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent posttransplantation colony stimulating factors during mycophenolate mofetil Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, California | |
| Beckman Research Institute, City of Hope | |
| Los Angeles, California, United States, 91010 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Germany | |
| Universitaet Leipzig - Chirurgische Klinik und Poliklinik I | |
| Leipzig, Germany, D-04103 | |
| Italy | |
| University of Torino | |
| Torino, Italy, 10126 | |
| Study Chair: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006251 History of Changes |
| Other Study ID Numbers: | 1533.00, FHCRC-1533.00, NCI-H00-0062, CDR0000068184 |
| Study First Received: | September 11, 2000 |
| Last Updated: | August 20, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
stage III breast cancer stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma recurrent childhood rhabdomyosarcoma stage IV renal cell cancer recurrent renal cell cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporins Cyclosporine Mycophenolic Acid Mycophenolate mofetil Fludarabine monophosphate Vidarabine |
Fludarabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 23, 2013