Expired Study
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Omaha, Nebraska 68198


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM), and autologous peripheral blood stem cell transplantation (APBSCT) vs historical control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and cyclophosphamide and APBSCT. - Determine the safety of this regimen in these patients. OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0. Patients are followed at days 30 and 100, at 6 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types: - Diffuse large B-cell - Composite (at least 50% of tumor showing diffuse histology) - Diffuse mixed cell - Immunoblastic - Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response) - Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation - Evidence of CD20 antigen expression in tumor tissue - Bidimensionally measurable disease - No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year - Adequate peripheral blood stem cells - At least 15,000,000 CD34+ cells/kg OR - At least 25,000 granulocyte macrophage colony-forming units/kg - No known brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - 19 to 70 Performance status: - Karnofsky 70-100% Life expectancy: - At least 4 months posttransplantation Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 2.0 mg/dL - No active obstructive hydronephrosis Cardiovascular: - Cardiac ejection fraction at least 40% for any of the following criteria: - Age 60 and over - Significant cardiac history (myocardial infarction or congestive heart failure) - Received greater than 350 mg/m^2 of prior doxorubicin - No New York Heart Association class III or IV heart disease Pulmonary: - DLCO at least 50% of predicted Other: - No evidence of severe organ dysfunction - No other major medical illnesses - No active infection requiring IV antibiotics - No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix - HIV negative - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study participation - Human antimouse antibody negative - No vulnerability PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy - At least 4 weeks since prior biologic therapy and recovered - No other concurrent biologic therapy for NHL Chemotherapy: - See Disease Characteristics - See Biologic therapy - At least 4 weeks since prior cytotoxic chemotherapy and recovered - No other concurrent chemotherapy or antineoplastic therapy for NHL Endocrine therapy: - No concurrent steroids except maintenance-dose steroids for noncancerous disease Radiotherapy: - See Disease Characteristics - See Biologic therapy - At least 4 weeks since prior radiotherapy and recovered - No concurrent external beam radiotherapy for NHL Surgery: - Not specified Other: - At least 4 weeks since prior immunosuppressants and recovered - No other concurrent participation on protocol involving non-FDA-approved drugs or biologics


NCT ID:

NCT00006695


Primary Contact:

Study Chair
Julie M. Vose, MD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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