Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019136
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Gene Therapy and Biological Therapy in Treating Patients With Ovarian Epithelial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER USING ANTI-CD3 STIMULATED PERIPHERAL BLOOD LYMPHOCYTES TRANSDUCED WITH A GENE ENCODING A CHIMERIC T-CELL RECEPTOR REACTIVE WITH FOLATE BINDING PROTEIN
Status:
COMPLETED
Status Verified Date:
2003-12
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 Interleukin-2 may stimulate a persons white blood cells to kill ovarian cancer cells Interleukin-2 combined with white blood cells that are gene-modified to recognize and kill ovarian cancer cells may be an effective treatment for recurrent or residual ovarian cancer
PURPOSE Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white blood cells in treating patients who have advanced ovarian epithelial cancer
PURPOSE Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white blood cells in treating patients who have advanced ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Determine the clinical response in patients with advanced ovarian epithelial cancer treated with intravenously administered allogeneic peripheral blood mononuclear cell-stimulated gene-modified lymphocytes MOv-PBL
Evaluate the ability of intravenously administered MOv-PBL to traffic to sites of ovarian cancer
Determine the duration of survival of transduced lymphocytes in the systemic circulation and at the tumor site in these patients
OUTLINE This is a dose-escalation study Patients are stratified by eligibility to receive interleukin-2 IL-2 yes vs no
Patients undergo leukapheresis The collected peripheral blood lymphocytes PBLs are stimulated with allogeneic peripheral blood mononuclear cells PBMCs followed by retroviral transduction with antiovarian cancer MOv-gamma chimeric receptor gene MOv-PBL MOv-PBL are then reinfused IV over 30-60 minutes followed by IL-2 IV over 15-30 minutes every 12 hours for up to 8 doses if eligible This course may be repeated at least once beginning 2-3 weeks later Patients receiving allogeneic PBMC-stimulated PBLs receive donor PBMCs subcutaneously at 1 and 8 days after each MOv-PBL infusion instead of IL-2
Cohorts of 3-6 patients in each stratum receive escalating doses of MOv-PBL until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 10 patients receive MOv-PBL without IL-2 followed by immunization with donor PBMCs as above
Patients are followed at 4 and 8 weeks and then periodically for survival
PROJECTED ACCRUAL Approximately 13-50 patients will be accrued for this study
Determine the clinical response in patients with advanced ovarian epithelial cancer treated with intravenously administered allogeneic peripheral blood mononuclear cell-stimulated gene-modified lymphocytes MOv-PBL
Evaluate the ability of intravenously administered MOv-PBL to traffic to sites of ovarian cancer
Determine the duration of survival of transduced lymphocytes in the systemic circulation and at the tumor site in these patients
OUTLINE This is a dose-escalation study Patients are stratified by eligibility to receive interleukin-2 IL-2 yes vs no
Patients undergo leukapheresis The collected peripheral blood lymphocytes PBLs are stimulated with allogeneic peripheral blood mononuclear cells PBMCs followed by retroviral transduction with antiovarian cancer MOv-gamma chimeric receptor gene MOv-PBL MOv-PBL are then reinfused IV over 30-60 minutes followed by IL-2 IV over 15-30 minutes every 12 hours for up to 8 doses if eligible This course may be repeated at least once beginning 2-3 weeks later Patients receiving allogeneic PBMC-stimulated PBLs receive donor PBMCs subcutaneously at 1 and 8 days after each MOv-PBL infusion instead of IL-2
Cohorts of 3-6 patients in each stratum receive escalating doses of MOv-PBL until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 10 patients receive MOv-PBL without IL-2 followed by immunization with donor PBMCs as above
Patients are followed at 4 and 8 weeks and then periodically for survival
PROJECTED ACCRUAL Approximately 13-50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T95-0040N | None | None | None |
| NCI-96-C-0011 | None | None | None |