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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418496
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : February 20, 2017
Information provided by (Responsible Party):
Paul Monk, Ohio State University Comprehensive Cancer Center

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 metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic melanoma.

Condition or disease Intervention/treatment Phase
Renal Cancer Melanoma Drug: Aldesleukin Drug: Sorafenib Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 8, 2006
Actual Primary Completion Date : February 28, 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Determine the progression free survival. [ Time Frame: Up to 12 weeks ]
  2. Evaluate in a preliminary manner the response rate. [ Time Frame: Up to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418496

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
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Principal Investigator: J. Paul Monk, M.D. Ohio State University

Additional Information:
Publications of Results:
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Responsible Party: Paul Monk, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00418496     History of Changes
Other Study ID Numbers: OSU-06006
NCI-2011-03199 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Keywords provided by Paul Monk, Ohio State University Comprehensive Cancer Center:
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs