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Sponsors and Collaborators: |
Memgen, LLC National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00796016 |
RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving gene-modified white blood cells together with fludarabine, cyclophosphamide, and rituximab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects of gene-modified white blood cells when given together with fludarabine, cyclophosphamide, and rituximab in treating patients with refractory or resistant B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: autologous Ad-CD154-transduced CLL B cells Drug: cyclophosphamide Drug: fludarabine phosphate Drug: rituximab Procedure: cytogenetic analysis Procedure: flow cytometry Procedure: fluorescence in situ hybridization Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: pharmacological study Procedure: protein expression analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase 1b Study of Repeated Doses of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35) in Combination With Fludarabine, Cyclophosphamide and Rituximab (FCR) in Subjects With Chronic Lymphocytic Leukemia (CLL) |
Estimated Enrollment: | 12 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive autologous Ad-CD154-transduced CLL B cells IV over 5-10 minutes on days 1, 15, and 29. Beginning 14 days later, patients receive rituximab IV over 1 hour on day 1 and fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 1 hour on days 2-4 in course 1. In courses 2 and 3, patients receive rituximab on day 1 and fludarabine phosphate and cyclophosphamide on days 1-3. Treatment with rituximab and chemotherapy repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative laboratory studies, including full and limited immunophenotyping (CD3, CD4, CD5, CD8, CD16, CD19, CD20, CD28, CD54, CD56, CD80, CD86, CD95) by flow cytometry; analysis of prognostic factors, including β-microglobulin, genomic aberrations (13q-, 11q-, +12q, 17p-, 6q-, and p53 deletion) by FISH, VH mutational status (unmutated/mutated), CD38+, and ZAP-70; and pharmacodynamic studies.
After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), meeting the following criteria:
Meets ≥ 1 of the following International Workshop on CLL 2008 "Indications for Treatment" Guidelines:
Has ≥ 1 of the following disease-related symptoms*:
Disease resistant or refractory to standard chemotherapy regimens containing alkylating agents and/or purine analogues, as defined by any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Rebecca and John Moores UCSD Cancer Center | Recruiting |
La Jolla, California, United States, 92093-0658 | |
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu |
Principal Investigator: | Januario E. Castro, MD | University of California, San Diego |
Responsible Party: | Memgen, LLC ( Regulatory Affairs Associate ) |
Study ID Numbers: | CDR0000617632, MEMGEN-080354, CLL-35-104 |
Study First Received: | November 21, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00796016 |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Cyclophosphamide Fludarabine monophosphate Recurrence |
Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |