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


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Adult Non-Hodgkin's Lymphoma


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

This study is no longer recruiting patients.

Sponsored by: Barbara Ann Karmanos Cancer Institute
Information provided by: National Cancer Institute (NCI)

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: Phase II trial to study the effectiveness of bone marrow transplantation plus chemotherapy in treating patients who have refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult Hodgkin's disease
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent small lymphocytic lymphoma
recurrent grade II follicular mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
refractory plasma cell neoplasm
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: etoposide
 Drug: filgrastim
 Drug: hydrocortisone
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: perfosfamide
 Drug: sargramostim
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Immune System and Disorders;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bone Marrow Transplantation in Patients With Refractory or High-Risk Non-Hodgkin's Lymphoma, Hodgkin's Disease, and Multiple Myeloma

Further Study Details: 

Study start: October 1993

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.

PROTOCOL 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

Criteria

PROTOCOL ENTRY 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.]

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--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

Location Information


Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

Study chairs or principal investigators

Rodger Dansey,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000063370; WSU-D-701-87; NCI-V94-0364
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002552
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 6, 2008



Page Updated: September 6, 2005
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