Status:
COMPLETED
Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Bayer
Novartis
Conditions:
Renal Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 m...
Detailed Description
Rationale: Previous research indicates that high dose aldesleukin produces tumor regression through upregulation of the patients' immune system. Research suggests that sorafenib directly targets tumor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00418496
Start Date
November 8 2006
End Date
October 1 2013
Last Update
February 20 2017
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210