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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004024 |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: sargramostim Biological: therapeutic autologous lymphocytes Procedure: surgical procedure Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy |
Estimated Enrollment: | 60 |
Study Start Date: | June 1997 |
OBJECTIVES:
OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected.
Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma
Resectable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 |
Study Chair: | Andrew E. Sloan, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000067243, WSU-C-1403-BT, NCI-G99-1567 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004024 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult subependymoma |
adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma adult diffuse astrocytoma |
Glioblastoma Anti-HIV Agents Immunologic Factors Astrocytoma Central Nervous System Neoplasms Antiviral Agents Immunosuppressive Agents Recurrence Muromonab-CD3 Brain Neoplasms |
Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Muromonab-CD3 Neoplasms by Site Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Nervous System Neoplasms |
Neoplasms by Histologic Type Anti-HIV Agents Nervous System Diseases Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Aldesleukin Oligodendroglioma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |