drugset / Trial / NCT01212887

Treated Blood Cells, Cyclophosphamide, Fludarabine Phosphate, and Aldesleukin in Treating Patients With Cancer

NCT01212887 ↗

Phase 1 Terminated 14 enrolled Cancer Research UK
Open-labelTreatment

Summary

RATIONALE: Placing a gene into T cells may improve the body's 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.

Timeline

Start
2007-08
Primary completion
2010-04
Completion
2010-04

Outcome

Outcome not reported

Stopped: “due to safety concerns and lack of efficacy”

Drugs

EvaluationDrugModalityDoseRoute
Subject MFEz T lymphocytes Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background aldesleukin Protein / enzyme biologic — Intravenous