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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003353 |
RATIONALE: High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow. Peripheral stem cell transplantation
PURPOSE: Phase II trial to study the effectiveness of high dose melphalan plus peripheral stem cell transplantation in treating patients who have primary systemic amyloidosis.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis |
Study Start Date: | July 1998 |
OBJECTIVES: I. Assess the response rate and overall survival of patients with biopsy proven primary amyloidosis following treatment with myeloablative chemotherapy and hematopoietic stem cell reconstitution. II. Evaluate the toxicity of high dose melphalan in this patient population.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 1 of the peripheral blood stem cell (PBSC) collection period and continuing until PBSC collection is completed. PBSC are collected beginning on day 5 of the collection period and continuing until the final target cell count is reached or for up to a maximum of 7 collections. If sufficient PBSCs are not harvested within a maximum of 7 collections, the patient is removed from the study. Within 30 days of PBSC collection, patients receive melphalan IV on day -1 of the infusion period and PBSC infusion on day 0. The infusion period continues until day 30. Patients receive G-CSF subcutaneously daily starting on day 1 and continuing until blood counts recover. Patients are followed every 3 months for 2 years, every 3 months for 3 additional years, and yearly thereafter.
PROJECTED ACCRUAL: A maximum of 33 patients will be accrued for this study over 2 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed primary amyloidosis Must have presence of paraprotein in serum or urine determined by immunoelectrophoresis/immunofixation No primary amyloidosis manifested only by carpal tunnel syndrome or purpura No history of secondary, familial, or localized amyloidosis No evidence of overt multiple myeloma: Lytic bone disease or pathological fractures OR At least 30% plasma cells in bone marrow
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified
Hematopoietic: Absolute granulocyte count at least 1000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 1000 u/L or less than 4 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Confirmed by echocardiogram: Ejection fraction at least 50% Interventricular septal thickness no greater than 15 mm No New York Heart Association classification II-IV Pulmonary: DLCO at least 50% FVC at least 60% FEV1 at least 55% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer No known sensitivity to E. coli derivatives
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon allowed Chemotherapy: At least 4 weeks since prior melphalan Lifetime cumulative dose of melphalan no greater than 150 mg No greater than 2 prior courses of chemotherapy Endocrine therapy: Prior dexamethasone allowed Radiotherapy: Not specified Surgery: Not specified
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 | |
Sylvester Cancer Center, University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
CCOP - Evanston | |
Evanston, Illinois, United States, 60201 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5265 | |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
New England Medical Center Hospital | |
Boston, Massachusetts, United States, 02111 | |
United States, Minnesota | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Tennessee | |
Vanderbilt Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 | |
Veterans Affairs Medical Center - Nashville | |
Nashville, Tennessee, United States, 37212 | |
United States, Wisconsin | |
CCOP - Marshfield Medical Research and Education Foundation | |
Marshfield, Wisconsin, United States, 54449 | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
Milwaukee, Wisconsin, United States, 53295 |
Study Chair: | Morie A. Gertz, MD | Mayo Clinic |
Study ID Numbers: | CDR0000066334, E-4A97 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003353 History of Changes |
Health Authority: | United States: Federal Government |
primary systemic amyloidosis |
Melphalan Metabolic Diseases Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Immunosuppressive Agents Multiple Myeloma Amyloidosis Hemorrhagic Disorders Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Alkylating Agents Metabolic Disorder Neoplasms, Plasma Cell |
Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type Metabolic Diseases |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Amyloidosis Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |