drugset / Trial / NCT00329368
Safety and Tolerability Study of FolateImmune in Combination With Cytokines in Patients With Refractory or Metastatic Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 1b clinical trial to assess the safety and tolerability of vaccination with EC90 (KLH-FITC) and GPI-0100 (adjuvant) followed by treatment with EC17 (Folate-FITC) in combination with low-dose cytokines (IL-2 and IFN-alpha) in patients with metastatic or refractory cancer.
Timeline
- Start
- 2005-09
- Primary completion
- 2007-12
- Completion
- 2008-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EC17 | Other / unclassified | 0.3 mg/kg | Subcutaneous |
| Subject | EC90 (KLH-FITC) | Vaccine | 1.2 mg | Subcutaneous |
| Subject | GPI-0100 | Other / unclassified | 3 mg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 7 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 12 iu | Subcutaneous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 3 iu | Subcutaneous |