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

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ClinicalTrials.gov Identifier: NCT00418496
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : February 20, 2017
Sponsor:
Collaborators:
Bayer
Novartis
Information provided by (Responsible Party):
Paul Monk, Ohio State University Comprehensive Cancer Center

January 2, 2007
January 4, 2007
February 20, 2017
November 8, 2006
February 28, 2013   (Final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) [ Time Frame: up to 1 year ]
Determine the MTD for high dose (HD) aldesleukin and sorafenib in patients with metastatic or unresectable clear cell renal cell carcinoma and metastatic melanoma
  • Maximum Tolerated Dose
  • Toxicity of High Dose
Complete list of historical versions of study NCT00418496 on ClinicalTrials.gov Archive Site
  • Determine the progression free survival. [ Time Frame: Up to 12 weeks ]
  • Evaluate in a preliminary manner the response rate. [ Time Frame: Up to 12 weeks ]
  • Determine the progression free survival.
  • Evaluate in a preliminary manner the response rate.
  • Evaluate the activation of aldesleukin induced transcription factors (T cell PSTAT 5 activity) within patients immune cell subsets.
  • Measure circulating levels of VEGF, VEGFR, IFN-γ, IL-5, and CD4+, CD25+, FoxP3 cell number (T regs).
Not Provided
Not Provided
 
Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma
A Phase I Study of Bolus High Dose Interleukin-2 With Sorafenib (BAY 43-9006) in Patients With Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma
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.

Rationale: Previous research indicates that high dose aldesleukin produces tumor regression through upregulation of the patients' immune system. Research suggests that sorafenib directly targets tumors by inhibiting angiogenic activity with possibly some cytotoxicity. Angiogenic refers to the formation of new blood vessels that support tumor growth. Cytotoxicity is the measurement of a chemical's ability to damage or kill cancer cells. Researchers have hypothesized that the complementary ways aldesleukin and sorafenib work, and their non-overlapping toxicity profiles, may create a reasonable combination for the treatment of metastatic renal cell carcinoma and metastatic melanoma. The current Phase I study will evaluate toxicity in patients through assessing various dose levels of sorafenib in combination with aldesleukin.

Purpose: The primary objective is to determine the maximum tolerated dose and characterize the toxicity of high dose aldesleukin and sorafenib in patients with unresectable or metastatic clear cell renal carcinoma and metastatic melanoma. Secondary objectives include determining progression free survival in patients, evaluating in a preliminary manner response rates, and assessing other measurements in study participants.

Treatment: Study participants will be given bolus high dose aldesleukin and sorafenib. Aldesleukin will be provided through intravenous infusions on days 1 through 5. Each 5 day treatment is considered a cycle. The second cycle of aldesleukin will start on day 15. Two cycles are considered 1 course. All study participants will be given the same dose level of aldesleukin. No dose reductions will be permitted. Sorafenib will then be administered on day 29. Since this study will assess the maximum tolerated dose of sorafenib, some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study. Each group of 3 to 6 study participants will receive a higher dose of sorafenib until the maximum tolerated dose is established. Imagining studies will be performed to determine response to treatment during week 12. If the patient has stable or responding disease, a second course will be administered on the same schedule. Patients without disease response will be given one additional course of aldesleukin past maximal response. When it is decided that no further aldesleukin will be provided to patients, sorafenib at the Food and Drug Administration approved dose may be continued until there is a lack of clinical benefit or intolerable side effects develop. Several tests and exams will be given throughout the study to closely monitor patients.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Cancer
  • Melanoma
  • 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).
    Other Name: Proleukin
  • 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.
    Other Name: Nexavar
Experimental: Aldekleukin Plus Dose Escalation Sorafenib
Patients will be admitted to a dedicated nursing unit for HD aldesleukin administration. Patients will receive bolus aldesleukin at a dose of 600,000 IU/Kg every eight hours on days 1-5 with a goal of 10-12 doses.
Interventions:
  • Drug: Aldesleukin
  • Drug: Sorafenib
Monk P, Lam E, Mortazavi A, Kendra K, Lesinski GB, Mace TA, Geyer S, Carson WE 3rd, Tahiri S, Bhinder A, Clinton SK, Olencki T. A phase I study of high-dose interleukin-2 with sorafenib in patients with metastatic renal cell carcinoma and melanoma. J Immunother. 2014 Apr;37(3):180-6. doi: 10.1097/CJI.0000000000000023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2013
February 28, 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00418496
OSU-06006
NCI-2011-03199 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
Yes
Not Provided
Not Provided
Paul Monk, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
  • Bayer
  • Novartis
Principal Investigator: J. Paul Monk, M.D. Ohio State University
Ohio State University Comprehensive Cancer Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP