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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00244985 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: pegylated liposomal doxorubicin hydrochloride Drug: rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma |
Estimated Enrollment: | 42 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Myron S. Czuczman ) |
Study ID Numbers: | CDR0000447130, RPCI-RPC-0204 |
Study First Received: | October 25, 2005 |
Last Updated: | October 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00244985 |
Health Authority: | United States: Food and Drug Administration |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent small lymphocytic lymphoma recurrent adult diffuse large cell lymphoma |
recurrent adult diffuse mixed 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 |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle cell lymphoma Doxorubicin Recurrence |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Antibodies Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Antibiotics, Antineoplastic Pharmacologic Actions |