Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 8, 2006

Primary Completion Date

February 28, 2013

Study Completion Date

October 31, 2013

Conditions
Renal CancerMelanoma
Interventions
DRUG

Aldesleukin

600,000 IU/kg every 8 hours on days 1-5 (week 1) to a maximum of 12 doses. Another cycle of HD aldesleukin will be started on day 15 (week 3).

DRUG

Sorafenib

To be initiated at a dose of 200 mg orally. Once it is determined that no further HD aldesleukin therapy will be given, sorafenib may be given daily at the FDA approved dose of 400 mg twice daily until there is lack of clinical benefit or intolerable side effects develop.

Trial Locations (1)

43210

Ohio State University, Columbus

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT00418496 - Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma | Biotech Hunter | Biotech Hunter