Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004024
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
1999-11-01
Brief Title:
Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-C-1403-BT | None | None | None |
| NCI-G99-1567 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |