Ignite Creation Date:
2024-05-05 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00562640
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2007-11-21
Brief Title:
Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer Primary Peritoneal Cavity Cancer or Fallopian Tube Cancer Fludarabine Treatment Closed as of 12012009
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Dose Escalation Safety and Feasibility Study of WT1-Specific T Cells for the Treatment of Patients With Advanced Ovarian Primary Peritoneal and Fallopian Tube Carcinomas
Status:
COMPLETED
Status Verified Date:
2021-08
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 Giving colony-stimulating factors such as G-CSF helps stem cells move from the bone marrow to the blood so they can be collected Treating stem cells collected from the patients blood in the laboratory may increase the number of immune cells that can mount an immune response against the tumor The treated stem cells may help destroy any remaining tumor cells graft-versus-tumor effect Chemotherapy may also be given to the patient to prepare the bone marrow for the stem cell transplant
PURPOSE This phase I trial is studying the side effects and best dose of autologous T cells when given with or without cyclophosphamide and fludarabine in treating patients with recurrent or persistent advanced ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer fludarabine treatment closed as of 12012009
PURPOSE This phase I trial is studying the side effects and best dose of autologous T cells when given with or without cyclophosphamide and fludarabine in treating patients with recurrent or persistent advanced ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer fludarabine treatment closed as of 12012009
Detailed Description:
OBJECTIVES
To assess the safety and tolerability of in vitro expanded autologous WT1 specific T cells when administered alone or in combination with non-myeloablative immunosuppressive conditioning in patients with recurrent or persistent advanced WT1-positive ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer
To determine the maximum tolerated dose of autologous WT1 specific T cells in these patients
To quantitate alterations in the concentration of WT1 specific T cells in the blood at defined intervals post infusion with or without non-myeloablative immunosuppressive conditioning in order to gain estimates regarding their survival and proliferation
To assess the effects of the adoptively transferred T cells on the growth and progression of advanced ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer
OUTLINE This is a dose-escalation study of WT1 peptide-specific T cells
T-cell generation and isolation Patients undergo collection of peripheral blood stem cells PBMC from which T cells are purified stimulated in vitro with WT1 peptide-pulsed autologous EBV BLCL and expanded ex vivo
Stem cell mobilization and harvest Patients receive filgrastim G-CSF subcutaneously daily for five days PBMC are collected by leukapheresis on the fifth day and then cryopreserved for subsequent reinfusion into the patient in the event of prolonged cytopenia
Autologous T-cell infusion with or without conditioning chemotherapy fludarabine treatment closed as of 12012009 Approximately 4-6 weeks after T-cell sensitization patients receive an infusion of autologous WT1-specific T cells over 5-10 minutes on day 0 Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2 and fludarabine phosphate IV over approximately 30 minutes on days -6 to -2 After a 48-hour rest period patients receive autologous WT1-specific T cells Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with responsive or stable disease after completion of therapy may receive additional courses of autologous WT1-specific T cells every 14 days
Blood samples are obtained at baseline and periodically during study and assayed for alterations in circulating levels of WT1 peptide-specific T cells for biochemical indices of tumor burden and for radiologic evidence of tumor response Serum CA125 levels are measured and the number of T cells generating interferon gamma in response to autologous EBV BLCL is quantitated
After completion of study therapy patients are followed for up to 12 weeks
To assess the safety and tolerability of in vitro expanded autologous WT1 specific T cells when administered alone or in combination with non-myeloablative immunosuppressive conditioning in patients with recurrent or persistent advanced WT1-positive ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer
To determine the maximum tolerated dose of autologous WT1 specific T cells in these patients
To quantitate alterations in the concentration of WT1 specific T cells in the blood at defined intervals post infusion with or without non-myeloablative immunosuppressive conditioning in order to gain estimates regarding their survival and proliferation
To assess the effects of the adoptively transferred T cells on the growth and progression of advanced ovarian epithelial cancer primary peritoneal cavity cancer or fallopian tube cancer
OUTLINE This is a dose-escalation study of WT1 peptide-specific T cells
T-cell generation and isolation Patients undergo collection of peripheral blood stem cells PBMC from which T cells are purified stimulated in vitro with WT1 peptide-pulsed autologous EBV BLCL and expanded ex vivo
Stem cell mobilization and harvest Patients receive filgrastim G-CSF subcutaneously daily for five days PBMC are collected by leukapheresis on the fifth day and then cryopreserved for subsequent reinfusion into the patient in the event of prolonged cytopenia
Autologous T-cell infusion with or without conditioning chemotherapy fludarabine treatment closed as of 12012009 Approximately 4-6 weeks after T-cell sensitization patients receive an infusion of autologous WT1-specific T cells over 5-10 minutes on day 0 Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2 and fludarabine phosphate IV over approximately 30 minutes on days -6 to -2 After a 48-hour rest period patients receive autologous WT1-specific T cells Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with responsive or stable disease after completion of therapy may receive additional courses of autologous WT1-specific T cells every 14 days
Blood samples are obtained at baseline and periodically during study and assayed for alterations in circulating levels of WT1 peptide-specific T cells for biochemical indices of tumor burden and for radiologic evidence of tumor response Serum CA125 levels are measured and the number of T cells generating interferon gamma in response to autologous EBV BLCL is quantitated
After completion of study therapy patients are followed for up to 12 weeks
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 |
|---|---|---|---|
| MSKCC-06155 | None | None | None |