Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039091
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2002-06-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer Melanoma Acute Myeloid Leukemia Myelodysplastic Syndrome or Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Anti-CTLA-4 Humanized Monoclonal Antibody MDX-CTLA-4 NSC 732442 Previously 720801 in Patients Previously Vaccinated With GM-CSF-Based Autologous Tumor Vaccines CTEP Protocol Number P-5708 and Patients With Acute Myelogenous Leukemia Myelodysplasia and Non-Small Cell Lung Cancer Who Have Not Received a Prior Vaccine
Status:
TERMINATED
Status Verified Date:
2018-09
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:
This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer melanoma acute myeloid leukemia myelodysplastic syndrome or non-small cell lung cancer Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety of MDX-CTLA-4 in patients previously and not previously vaccinated with GM-CSF-based vaccines using lethally irradiated autologous melanoma ovarian cancer acute myelogenous leukemiamyelodysplasia or lung cancer cells
II To identify preliminary evidence of biologic activity and efficacy
OUTLINE
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1 Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 48 patients 12 per disease type 36 previously treated with a sargramostim GM-CSF-expressing autologous tumor cell vaccine and 12 not previously treated with this vaccine will be accrued for this study
I To determine the safety of MDX-CTLA-4 in patients previously and not previously vaccinated with GM-CSF-based vaccines using lethally irradiated autologous melanoma ovarian cancer acute myelogenous leukemiamyelodysplasia or lung cancer cells
II To identify preliminary evidence of biologic activity and efficacy
OUTLINE
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1 Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 48 patients 12 per disease type 36 previously treated with a sargramostim GM-CSF-expressing autologous tumor cell vaccine and 12 not previously treated with this vaccine 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 |
|---|---|---|---|
| CDR0000069349 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA105776 |
| 01-228 | None | None | None |
| R21CA105776 | NIH | None | None |