Overview
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
Status:
Completed
Completed
Trial end date:
2003-10-01
2003-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Barbara Ann Karmanos Cancer InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Carmustine
Cortisol succinate
Cyclophosphamide
Cytarabine
Etoposide
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Leucovorin
Levoleucovorin
Methotrexate
Sargramostim
Criteria
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease (HD), non-Hodgkin'slymphoma (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