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Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsored by: Barbara Ann Karmanos Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002552
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.


Condition Intervention Phase
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: filgrastim
Drug: leucovorin calcium
Drug: methotrexate
Drug: perfosfamide
Drug: sargramostim
Drug: therapeutic hydrocortisone
Procedure: allogeneic bone marrow transplantation
Procedure: autologous bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Procedure: syngeneic bone marrow transplantation
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Bone Marrow Transplantation Cancer Hodgkin's Disease Lymphoma Multiple Myeloma
Drug Information available for: Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Carmustine Sargramostim Granulocyte-macrophage colony-stimulating factor Etoposide phosphate Calcium gluconate Perfosfamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: October 1993
Detailed Description:

OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma. II. Evaluate any prognostic factors.

OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy) receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Prior to autologous bone marrow transplantation and following myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL), and multiple myeloma (MM) meeting the following requirements: Refractory to or at high risk following prior therapy Responded with at least a partial response to last cytoreductive regimen No bulky disease (individual tumor diameter larger than 5 cm) Eligible HD: CNS involvement at original presentation and currently in complete response (CR) Relapsed within 1 year following completion of front-line MOPP or ABVD Relapsed at any time following front-line MOPP/ABVD or other hybrid Eligible NHL: Any grade lymphoma with CNS involvement at original presentation and currently in CR High-grade lymphomas (International Working Formulation H-J) with marrow involvement at original presentation and currently in CR, EXCEPT: Immunoblastic lymphoma and large cell (IWF G and H) with bone marrow involvement with small cleaved cell at original presentation High-/intermediate-grade lymphomas (IWF D-J) in relapse after adequate front-line therapy High-/intermediate-grade lymphomas (IWF D-J) that failed to achieve CR with adequate front-line therapy Low-grade lymphomas (IWF A-C) with B symptoms at original presentation and relapse after front-line therapy Low-grade lymphomas (IWF A-C) in relapse within 1 year following last chemotherapy Low-grade lymphomas (IWF A-C) with documented histologic conversion Eligible MM: Diagnosis based on either presence of both Group I diagnostic criteria OR One Group I criterion and all Group II criteria Group I diagnostic criteria: Plasma cells and/or myeloma cells greater than 10% in bone marrow Biopsy-proven plasmacytoma in bone or soft tissue Group II diagnostic criteria: Monoclonal serum protein spike Urinary myeloma protein Osteolytic lesions on radiologic examination Generalized osteoporosis suffices if plasma cells in marrow exceed 30% Myeloma cells in at least 2 peripheral blood smears Stage II/III disease documented sometime during clinical course Stage III defined by presence of at least 1 of the following: Hemoglobin less than 8.5 g/dl Serum calcium greater than 12 mg/dl Advanced lytic bone lesions High M-component production rates: IgG greater than 7 g/dl IgA greater than 5 g/dl Urinary light chain greater than 4 g/24 hours Stage II disease defined by absence of Stage III characteristics but presence of at least 1 of the following: Hb less than 10 g/dl More than 1 osteolytic lesion, none advanced IgG greater than 5 g/dl IgA greater than 3 g/dl Bone marrow donor available for lymphoma patients with marrow involvement Perfosfamide-purged autologous transplant allowed in patients with no matched sibling donor if: Marrow involvement is limited (less than 30% tumor cells on smears and in bilateral iliac crest biopsies) AND Age is under 60 Donor requirements: Excellent physical condition by history, lab studies, PE No physiologic, psychologic, or medical inability to tolerate the procedure No increased anesthetic risk No HIV infection Priority of multiple donors (in order given): ABO compatible Age over 18 Same sex as recipient A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-2 Life expectancy: No severe limitation due to nonmalignant disease Hematopoietic: Not specified Hepatic: No severe hepatic disease Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: No severe renal disease Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease LVEF at least 50% Pulmonary: No severe pulmonary disease FEV1 and FVC at least 75% of normal Other: No history of severe cystitis with cyclophosphamide No HIV infection No severe personality disorder or severe mental illness No other condition that would markedly increase the morbidity and mortality of transplantation (e.g., substance abuse) Patients with borderline parameters of organ function, performance status, or mental status are entered at the discretion of the transplant team

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002552

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Roger Dansey, MD Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000063370, WSU-D-701-87, NCI-V94-0364
Study First Received: November 1, 1999
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00002552  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
recurrent small lymphocytic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
adult unfavorable prognosis Hodgkin lymphoma
childhood unfavorable prognosis Hodgkin lymphoma

Study placed in the following topic categories:
Hydrocortisone
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Methotrexate
Hodgkin Disease
Etoposide
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Leukemia, B-cell, chronic
Carmustine
Multiple Myeloma
Folic Acid
B-cell lymphomas
Hydrocortisone acetate
Lymphoma, Non-Hodgkin
Hodgkin's disease
Blood Protein Disorders
Lymphoma, Follicular
Leucovorin
Paraproteinemias
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Vitamins
Abortifacient Agents
Cardiovascular Diseases
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Immune System Diseases
Growth Substances
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on January 14, 2009