A Phase I Study of EC90 With GPI-0100 Adjuvant Followed by EC17 With Cytokines (Interleukin-2 [IL-2] and Interferon-alpha [IFN-alpha]) in Patients With Refractory or Metastatic Cancer

NCT00329368 Phase 1 COMPLETED

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.

Details

Lead sponsor	Endocyte
Phase	Phase 1
Status	COMPLETED
Enrolment	13
Start date	2005-09
Completion	2008-06

Conditions

• Cancer

Interventions

• EC90 (KLH-FITC)
• GPI-0100
• EC17 (Folate-FITC)
• Interleukin-2
• Interferon-alpha

Primary outcomes

• Safety — Initial dose of study therapy through 30 days post last dose of study therapy
• Tolerability — Initial dose of study therapy through 30 days post last dose of study therapy
• Anti-tumor Activity — From initial dose of study therapy to disease progression

Countries

United States