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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00349206 |
Purpose
RATIONALE: Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Skin Cancer |
Drug: Sorafenib Tosylate Drug: Temsirolimus |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of the Combination of BAY43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma |
| Estimated Enrollment: | 69 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sorafenib + Temsirolimus
Phase I: Temsirolimus by vein (IV) on days 1, 8,15, and 22 and oral Sorafenib daily on days 1-28.
|
Drug: Sorafenib Tosylate
Starting dose 400 mg by mouth (PO) every day.
Other Name: Bay 43-9006
Drug: Temsirolimus
Starting dose 15 mg IV weekly
Other Names:
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of temsirolimus followed by a phase II, open-label study.
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Ten additional patients are treated at the MTD.
Patients undergo a mandatory blood draw and tumor biopsy (punch biopsy, core-needle biopsy with or without ultrasound guidance, or excisional biopsy) at baseline (unless tissue is available from a prior biopsy or resection). Reverse phase protein array analysis is conducted on these pre-treatment specimens along with biomarker studies.
After completion of study treatment, patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas M.D. Anderson CCOP Research Base | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Kevin Kim, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Kevin B. Kim, MD, BA / Associate Professor, M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00349206 History of Changes |
| Other Study ID Numbers: | 2005-0215, U01CA062461, P30CA016672, MDA-2005-0215, NCI-7149, CDR0000480157 |
| Study First Received: | July 5, 2006 |
| Last Updated: | May 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage III melanoma stage IV melanoma recurrent melanoma Sorafenib |
Bay43-9006 Temsirolimus CCI-779 |
|
Skin Neoplasms Melanoma Neoplasms by Site Neoplasms Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Sirolimus Everolimus Sorafenib |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |