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

Completed · Phase 1

Conditions studied: Renal Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT00418496

Run by

Ohio State University Comprehensive Cancer Center

People needed

17

Starts

2006-11-08

Expected to finish

2013-10-01

Last updated by the study team

2017-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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