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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study will be to determine the toxicity and Maximum Tolerated Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Bayer; Novartis
• Treatments: Aldesleukin; Interleukin-2; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed evidence of metastatic/ unresectable clear cell renal carcinoma.

• Patients must have metastatic melanoma with no brain metastases.

• Patients must have measurable disease.

• No prior systemic treatment (One prior systemic treatment is allowed for metastatic melanoma patients. Excluded prior therapies include prior high dose aldesleukin, sorafenib and DTIC/TMZ.)

• Age ≥ 18 years or older

Exclusion Criteria:

• Patients who are undergoing or have undergone surgery S weeks.

• Patients who are pregnant (because of possible side effects on the fetus) Effective contraception will be discussed with each patient.

• Patients with uveal melanoma.