Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

July 31, 2011

Study Completion Date

September 30, 2012

Conditions
Renal Cell Carcinoma (RCC)
Interventions
BIOLOGICAL

Chimeric monoclonal antibody cG250

"First Cycle: cG250 10 mg/m² intravenous infusion, weekly for five weeks, followed by a two-week break. 1st \& 5th dose will be trace-labeled with a radioactive substance detectable on a PET scanner (124I-cG250).~Second cycle (investigator discretion): cG250 10 mg/m² intravenous infusion, weekly for four weeks followed by a two-week break. No 124I-cG250 will be used in the 2nd cycle.~Up to 2 cycles available."

DRUG

Sunitinib malate

"First Cycle: Sunitinib 50 mg orally daily for 4 weeks (starts 8th day of 1st treatment cycle), followed by a two-week period off sunitinib.~Second cycle (investigator discretion): Sunitinib 50 mg orally daily for 4 weeks (starts on 1st day of 2nd treatment cycle), followed by a two-week period off sunitinib.~Up to 2 cycles available on-study."

Trial Locations (1)

3084

Austin Health (Ludwig Institute Oncology Unit), Heidelberg

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Heidelberg Pharma AG

INDUSTRY

lead

Ludwig Institute for Cancer Research

OTHER