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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602121 |
RATIONALE: Vaccines made from a patient's gene-modified tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of autologous gene-modified tumor cells and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: autologous tumor cell vaccine Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | PRIMAL: PROLONGED IMMUNISATION WITH AUTOLOGOUS CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS FOR TREATMENT OF B-CHRONIC LYMPHOCYTIC LEUKEMIA (B-CLL) |
Estimated Enrollment: | 15 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo peripheral blood collection and/or leukapheresis to obtain B-cell chronic lymphocytic leukemia (CLL) cells. B-cell CLL cells are isolated and transduced by the human interleukin-2 (IL-2) adenoviral vector and stimulated with CD40-ligand for the production of CD40-ligand-expressing and IL-2 gene-modified autologous tumor cells.
Patients receive CD40-ligand-expressing and IL-2 gene-modified autologous tumor cell vaccine subcutaneously once weekly in weeks 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. Patients achieving a side population tumor cell response or clinical response receive additional vaccinations once weekly in weeks 32, 36, 40, 44, 48, and 52.
Blood is collected periodically to assess immune response as measured by numeric and phenotypical characterization of circulating leukocyte sub-populations, including analysis of CD4+, CD8+ and CD25+ T-lymphocytes and CD16+ and CD56+ NK cells and tumor side-population cells. When available, leukocytes are also assessed for the number of precursors reacting against autologous B-cell CLL cells using interferon-gamma ELISPOT assay. Plasma is tested for the presence of immunoglobulins against autologous B-cell CLL cells.
After completion of study treatment, patients are followed annually for 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No autoimmune disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Vicky Torrano 832-824-7821 | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Vicky Torrano 832-824-7821 |
Study Chair: | Malcolm K. Brenner, MD, PhD | Baylor College of Medicine |
Responsible Party: | Dan L. Duncan Cancer Center at Baylor College of Medicine ( Malcolm K. Brenner ) |
Study ID Numbers: | CDR0000582371, BCM-H-19747, BCM-PRIMAL |
Study First Received: | January 24, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00602121 |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia |
stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |