Ignite Creation Date:
2024-05-05 @ 10:56 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01212887
Status:
TERMINATED
Last Update Posted:
2012-02-28
First Post:
2010-09-30
Brief Title:
Treated Blood Cells Cyclophosphamide Fludarabine Phosphate and Aldesleukin in Treating Patients With Cancer
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
A Cancer Research UK Phase I Trial of Adoptive Transfer of Autologous Tumor Antigen-Specific T Cells With Preconditioning Chemotherapy and Intravenous IL2 in Patients With Advanced CEA Positive Tumors
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to safety concerns and lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Placing a gene into T cells may improve the bodys ability to recognize cancer cells and build an immune response to fight cancer Drugs used in chemotherapy such as cyclophosphamide and fludarabine phosphate work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as aldesleukin may stimulate the immune system in different ways and stop cancer cells from growing Giving specially treated T cells together with cyclophosphamide fludarabine phosphate and aldesleukin may kill more tumor cells
PURPOSE This phase I clinical trial is studying the side effects and best dose of treated T cells when given together with cyclophosphamide fludarabine phosphate and aldesleukin in treating patients with cancer
PURPOSE This phase I clinical trial is studying the side effects and best dose of treated T cells when given together with cyclophosphamide fludarabine phosphate and aldesleukin in treating patients with cancer
Detailed Description:
OBJECTIVES
Primary
To evaluate the feasibility of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes in combination with preconditioning chemotherapy comprising cyclophosphamide and fludarabine phosphate plus aldesleukin in patients with CEA-positive tumors
To assess the toxicity of this regimen in these patients
To determine the dose of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes required to give optimal survival of these cells in the circulation recommended phase II dose
Secondary
To assess whether MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes isolated from the circulation are functional
To determine the preliminary tumor response to MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
To evaluate the safety of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
OUTLINE This is a phase I dose-escalation study of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
Patients undergo leukapheresis 7-14 days before study therapy begins Cells are then transduced with a retrovirus vector and expanded to produce MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
Patients receive preconditioning chemotherapy comprising fludarabine phosphate IV over 15 minutes on days -5 to -1 or cyclophosphamide IV over 1 hour on days -7 to -6 and fludarabine phosphate IV over 15 minutes on days -5 to -1 They receive MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes IV over 30 minutes on day 0 Patients also receive high-dose aldesleukin IV over 15 minutes every 8 hours for up to 12 doses beginning on day 0 in the absence of disease progression or unacceptable toxicity If there is evidence of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes survival patients may receive additional high-dose aldesleukin
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies Some patients may undergo a tumor biopsy
After completion of study treatment patients are followed up every 2 weeks for 6 weeks every 4 weeks for 6 months every 3 months for 1 year and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
To evaluate the feasibility of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes in combination with preconditioning chemotherapy comprising cyclophosphamide and fludarabine phosphate plus aldesleukin in patients with CEA-positive tumors
To assess the toxicity of this regimen in these patients
To determine the dose of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes required to give optimal survival of these cells in the circulation recommended phase II dose
Secondary
To assess whether MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes isolated from the circulation are functional
To determine the preliminary tumor response to MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
To evaluate the safety of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
OUTLINE This is a phase I dose-escalation study of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
Patients undergo leukapheresis 7-14 days before study therapy begins Cells are then transduced with a retrovirus vector and expanded to produce MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes
Patients receive preconditioning chemotherapy comprising fludarabine phosphate IV over 15 minutes on days -5 to -1 or cyclophosphamide IV over 1 hour on days -7 to -6 and fludarabine phosphate IV over 15 minutes on days -5 to -1 They receive MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes IV over 30 minutes on day 0 Patients also receive high-dose aldesleukin IV over 15 minutes every 8 hours for up to 12 doses beginning on day 0 in the absence of disease progression or unacceptable toxicity If there is evidence of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes survival patients may receive additional high-dose aldesleukin
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies Some patients may undergo a tumor biopsy
After completion of study treatment patients are followed up every 2 weeks for 6 weeks every 4 weeks for 6 months every 3 months for 1 year and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
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 |
|---|---|---|---|
| CRUK-PH1105 | None | None | None |
| CRUK-MFEz | None | None | None |
| EUDRACT-2005-004085-16 | None | None | None |
| EU-21070 | None | None | None |