Safety and Tolerability Study of FolateImmune in Combination With Cytokines in Patients With Refractory or Metastatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

December 31, 2007

Study Completion Date

June 30, 2008

Conditions
Cancer
Interventions
BIOLOGICAL

EC90 (KLH-FITC)

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

BIOLOGICAL

GPI-0100

3.0mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first treatment cycle, 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 followed by 2 observation weeks for each cycle.

DRUG

Interleukin-2

Low dose (7-12 MIU) IL-2 administered subcutaneously three times per week (MWF) for 3 consecutive weeks during the first cycle, 4 consecutive weeks during cycle 2 and additional cycles

DRUG

Interferon-alpha

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

Trial Locations (3)

48910

Great Lakes Cancer Institute Breslin Cancer Center, Lansing

62794

Southern Illinois University School of Medicine, Springfield

77030

The Methodist Hospital, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endocyte

INDUSTRY