A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

March 31, 2009

Conditions
Renal Cell Carcinoma
Interventions
BIOLOGICAL

EC90 (KLH-FITC)

1.2mg in combination with adjuvant GPI-0100 administered subcutaneously (beneath the skin) weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

BIOLOGICAL

GPI-0100

3.0 mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

DRUG

EC17 (Folate-FITC)

0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks for the first two treatment cycles and then 3 days per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

DRUG

Interleukin-2

7.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 2.5 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

DRUG

Interferon-alpha

3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

Trial Locations (3)

77030

The Methodist Hospital Research Institute, Houston

68198-7680

University of Nebraska Medical Center, Omaha

07601

Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endocyte

INDUSTRY