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Sponsored by: |
University of Nebraska |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00007852 |
RATIONALE: Monoclonal antibodies such as rituximab 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 tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: rituximab Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma |
Study Start Date: | September 2000 |
OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine, etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation. II. Determine the toxicity profile of this regimen in these patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population.
OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days
PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma Transplantation candidate Primary induction failure Chemotherapy refractory disease Received at least 3 prior chemotherapy regimens OR Diagnosis of mantle cell lymphoma No history of T-cell lymphoma No relapse or progression after rituximab therapy within 3 months before transplantation
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3* Platelet count more than 50,000/mm3* Hemoglobin more than 9.0 g/dL* *Unless due to lymphomatous involvement of the marrow Hepatic: Not specified Renal: Not specified Other: No serious disease or condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for transient control or prevention of nausea or vomiting Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed Radiotherapy: No concurrent external beam radiotherapy during transplantation therapy Surgery: Not specified Other: No other concurrent antitumoral or investigational agents
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-3330 |
Study Chair: | Julie M. Vose, MD | University of Nebraska |
Study ID Numbers: | CDR0000068305, UNMC-045-00, NCI-V00-1634 |
Study First Received: | January 6, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00007852 History of Changes |
Health Authority: | United States: Federal Government |
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 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 |
Antimetabolites Anti-Infective Agents Melphalan Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Etoposide phosphate Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic |
Leukemia, B-cell, Chronic Lymphoma, Large-cell Alkylating Agents Etoposide Lymphoma Cytarabine Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Carmustine Immunosuppressive Agents Antiviral Agents Recurrence Lymphatic Diseases Burkitt's Lymphoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rituximab Physiological Effects of Drugs Carmustine |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Alkylating Agents Cytarabine |