Search / Trial NCT00002552

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

Launched by BARBARA ANN KARMANOS CANCER INSTITUTE · May 21, 2004

Trial Information

Current as of December 07, 2024

Completed

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

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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

Trial Officials

Roger Dansey, MD

Study Chair

Barbara Ann Karmanos Cancer Institute

About Barbara Ann Karmanos Cancer Institute

The Barbara Ann Karmanos Cancer Institute, a leading nonprofit cancer research and treatment center located in Detroit, Michigan, is dedicated to advancing innovative cancer therapies and improving patient outcomes through rigorous clinical trials. Affiliated with Wayne State University, the institute emphasizes a multidisciplinary approach, integrating cutting-edge research with compassionate patient care. With a commitment to translating laboratory discoveries into effective treatments, Karmanos plays a pivotal role in the national landscape of cancer research, focusing on personalized medicine and the development of novel therapeutic strategies to combat various forms of cancer.

Locations

Detroit, Michigan, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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