drugset / Trial / NCT00485563
A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 \[KLH-FITC\] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. All patients will undergo imaging with the investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial.
Timeline
- Start
- 2007-06
- Primary completion
- 2008-08
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EC17 | Other / unclassified | 0.3 mg/kg | Subcutaneous |
| Subject | EC90 | Vaccine | 1.2 mg | Subcutaneous |
| Background | GPI-0100 | Other / unclassified | 3 mg | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | 2.5e+06 iu | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | 7e+06 iu | Subcutaneous |
| Background | interferon alfa-2b | Protein / enzyme biologic | 3e+06 iu | Subcutaneous |