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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 |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim Drug: methotrexate Drug: thiotepa Radiation: 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:
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: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00621036 History of Changes |
Health Authority: | Unspecified |
primary central nervous system lymphoma |
Antimetabolites Immunoproliferative Disorders Immunoglobulin Idiotypes Immunologic Factors Central Nervous System Lymphoma, Primary Folic Acid Antagonists Immunosuppressive Agents Thiotepa |
Folic Acid Lymphatic Diseases Antibodies Methotrexate Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immunoglobulin Idiotypes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses Abortifacient Agents Methotrexate Lymphoma Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Immunoglobulins Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Antirheumatic Agents Lymphoproliferative Disorders |