Search / Trial NCT00002481

Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Launched by ST. LUKE'S MEDICAL CENTER · Apr 28, 2004

Trial Information

Current as of November 03, 2024

Unknown status

Keywords

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 Recurrent Small Lymphocytic Lymphoma Extranodal Marginal Zone B Cell Lymphoma Of Mucosa Associated Lymphoid Tissue Nodal Marginal Zone B Cell Lymphoma Splenic Marginal Zone Lymphoma

Description

OBJECTIVES: I. Determine the toxicity and activity of cyclophosphamide, etoposide, total body irradiation, and autologous bone marrow transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma. II. Determine the feasibility of pretransplantation cytoreduction with a regimen of high-dose cytarabine, cisplatin, and dexamethasone in this patient population. III. Determine the feasibility of posttransplantation radiotherapy given to sites of residual disease (involved-field "boost" irradiation) in this patient population. OUTLINE: Patients are stratified by disease status (...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically proven or unequivocal radiologic evidence of non-Hodgkin's lymphoma that has relapsed or is refractory after first-line chemotherapy Unequivocal radiologic evidence of relapse defined as the presence of enlarged (at least 2 cm diameter) lymph nodes by CT scan or lymphangiogram Biopsy of accessible lymph nodes to confirm relapse encouraged Low-, intermediate-, or high-grade disease Normal bilateral bone marrow biopsy at time of bone marrow collection required (cellularity at least 20% and no histologic evidence of tumor) History of marrow involvement allowed if present marrow is histologically normal No disease progression in a previously irradiated site 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: 16 and over Performance status: CALGB 0-2 Karnofsky 70-100% Life expectancy: More than 2 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times normal SGOT and SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction normal by MUGA scan No uncontrolled or severe cardiovascular disease, including the following: Myocardial infarction within the past 6 months Congestive heart failure Symptomatic angina (despite optimal medical management) Life-threatening arrhythmia or hypertension Pulmonary: Pulmonary function tests (DLCO and spirometry) greater than 60% predicted Other: HIV negative No serious organ dysfunction (unless caused by lymphoma) No active bacterial, viral, or fungal infection No active peptic ulcer disease No uncontrolled diabetes mellitus No other malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No other serious medical or psychiatric illness that would preclude study Not pregnant
  • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior nitrosourea allowed if cumulative dose no more than 600 mg/m2 Prior bleomycin allowed if cumulative dose no more than 300 units/m2 Prior doxorubicin allowed if cumulative dose no more than 450 mg/m2 No prior high-dose etoposide (more than 1,800 mg/m2) No prior high-dose cyclophosphamide (more than 100 mg/kg) No chemotherapy within 4 weeks (no melphalan, nitrosourea, or mitomycin within 6 weeks) prior to bone marrow collection No prior salvage therapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to liver or lung Prior other radiotherapy allowed if doses do not exceed the following limits: 1,400 cGy to the mediastinum 1,400 cGy to the whole abdomen 4,000 cGy to the CNS Surgery: Not specified

About St. Luke's Medical Center

St. Luke's Medical Center is a leading healthcare institution dedicated to advancing medical research and enhancing patient care through innovative clinical trials. With a commitment to excellence in clinical research, St. Luke's collaborates with a diverse team of experienced professionals and researchers to evaluate cutting-edge therapies and interventions across various medical fields. The center prioritizes patient safety and ethical standards while striving to contribute valuable insights to the medical community. By fostering a supportive environment for both participants and investigators, St. Luke's Medical Center plays a pivotal role in shaping the future of healthcare through rigorous scientific inquiry and compassionate care.

Locations

Milwaukee, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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