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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012207 |
Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: aldesleukin Biological: therapeutic autologous lymphocytes Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Procedure: adjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2000 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1. Courses repeat every 3-4 weeks for a total of 6 courses.
Beginning 4 weeks after the last course of chemotherapy (and lymph nodes ≤ 5 cm diameter or ≤ 5,000 circulating CD20+ lymphocytes/mm^3), patients receive autologous CD8+ CTL clones IV over 30 minutes. Courses repeat every 2-5 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 14 days, beginning 2 hours after the last infusion of CD8+ CTL clones.
After course 2 or 3 of immune cells, all patients undergo surgical lymph node biopsy to determine if immune cells are moving to the lymph nodes.
Patients are followed monthly for 1 year and then annually for 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma
Indolent B-cell lymphomas including any of the following subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Study Chair: | Oliver W. Press, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000068494, FHCRC-1503.00, NCI-G01-1921 |
| Study First Received: | March 3, 2001 |
| Last Updated: | February 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00012207 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 mantle cell lymphoma |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma refractory chronic lymphocytic leukemia |
|
Anti-Inflammatory Agents Prednisone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Mantle Cell Lymphoma Cyclophosphamide Hormones Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Leukemia Anti-Retroviral Agents |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Alkylating Agents Lymphoma Anti-HIV Agents Immunoproliferative Disorders Antineoplastic Agents, Hormonal Adjuvants, Immunologic Vincristine Antimitotic Agents Antiviral Agents Glucocorticoids Immunosuppressive Agents Recurrence Lymphatic Diseases |
|
Anti-Inflammatory Agents Anti-Infective Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Leukemia Anti-Retroviral Agents Therapeutic Uses Lymphoma Alkylating Agents |
Anti-HIV Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Antiviral Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin |