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Sponsored by: |
Simmons Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00621036 |
RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine Drug: methotrexate Drug: sargramostim Drug: thiotepa Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With CNS Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE:
After completion of therapy, patients are followed periodically for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or CSF cytologically confirmed CNS lymphoma with any of the following clinical histories:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent immunosuppressives, including corticosteroids
United States, Texas | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 |
Principal Investigator: | Elizabeth Maher, MD, PhD | Simmons Cancer Center |
Study ID Numbers: | CDR0000587504, SCCC-102007-035, SCCC-02F07 |
Study First Received: | February 21, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00621036 |
Health Authority: | Unspecified |
primary central nervous system lymphoma |
Folic Acid Lymphatic Diseases Antibodies Immunoproliferative Disorders Immunoglobulin Idiotypes Methotrexate |
Lymphoproliferative Disorders Lymphoma Immunoglobulins Thiotepa Central nervous system lymphoma, primary |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |