Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004022
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
1999-11-01
Brief Title:
Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Immunotherapy for Malignant Melanoma - 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 in treating patients who have stage III or stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim GM-CSF followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with surgery in terms of response rate in patients with stage III or IV malignant melanoma
Determine the immunogenicity of malignant melanoma in this patient population
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 surgical resection of tumor on week 1 Within 1-2 weeks of surgery patients are vaccinated with irradiated autologous tumor cells and sargramostim GM-CSF then receive GM-CSF alone intradermally at vaccination sites daily for 4 days Patients are revaccinated 2 weeks later
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody OKT3 and interleukin-2 producing activated T lymphocytes The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days Treatment continues in the absence of disease progression or unacceptable toxicity
Patients may receive one additional course of immunotherapy as above
Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim GM-CSF followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with surgery in terms of response rate in patients with stage III or IV malignant melanoma
Determine the immunogenicity of malignant melanoma in this patient population
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 surgical resection of tumor on week 1 Within 1-2 weeks of surgery patients are vaccinated with irradiated autologous tumor cells and sargramostim GM-CSF then receive GM-CSF alone intradermally at vaccination sites daily for 4 days Patients are revaccinated 2 weeks later
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody OKT3 and interleukin-2 producing activated T lymphocytes The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days Treatment continues in the absence of disease progression or unacceptable toxicity
Patients may receive one additional course of immunotherapy as above
Patients are followed every 3 months for 2 years 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 |
|---|---|---|---|
| NCI-G99-1565 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-C-1403-ME | None | None | None |