Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma

NCT00002552 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000063370P30CA022453WSU-D-701-87NCI-V94-0364
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Interventions

filgrastim BIOLOGICAL

sargramostim BIOLOGICAL

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

etoposide DRUG

leucovorin calcium DRUG

methotrexate DRUG

perfosfamide DRUG

therapeutic hydrocortisone DRUG

allogeneic bone marrow transplantation PROCEDURE

autologous bone marrow transplantation PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

syngeneic bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

Filgrastim; sargramostim; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Leucovorin; Methotrexate; perfosfamide; Hydrocortisone; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Roger Dansey, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 24, 2004
• Study Start: October 1, 1993
• Primary Completion: September 1, 2001
• Study Completion: October 1, 2003
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

US (1)