Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
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|ClinicalTrials.gov Identifier: NCT00004024|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 5, 2013
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 or disease||Intervention/treatment||Phase|
|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 2|
- Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma.
- Determine the immunogenicity of malignant gliomas in patients treated with this regimen.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy|
|Study Start Date :||June 1997|
|Primary Completion Date :||January 2004|
|Study Completion Date :||January 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004024
|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|