Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00281957 |
RATIONALE: Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.
PURPOSE: This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: sorafenib tosylate Drug: temsirolimus Drug: tipifarnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase II Trial of BAY 43-9006 (SORAFENIB; NSC-724772) With Either CCI-779 (TEMSIROLIMUS; NSC-683864) or R115777 (TIPIFARNIB: NSC-702818) in Metastatic Melanoma |
Estimated Enrollment: | 120 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
|
Drug: sorafenib tosylate
Given orally
Drug: temsirolimus
Given IV
|
Arm II: Experimental
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
|
Drug: sorafenib tosylate
Given orally
Drug: tipifarnib
Given orally
|
OBJECTIVES:
Primary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All patients undergo CT scan or MRI at baseline and in week 9.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma of cutaneous origin
Unresectable disease
Residual or recurrent disease after prior surgery for stage IV disease allowed
No history of brain metastases
PATIENT CHARACTERISTICS:
No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
PRIOR CONCURRENT THERAPY:
No concurrent use of any of the following:
Study Chair: | Kim A. Margolin, MD | Beckman Research Institute |
Investigator: | Vernon K. Sondak, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000454925, SWOG-S0438 |
Study First Received: | January 24, 2006 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00281957 |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus |
Sorafenib Recurrence Tipifarnib Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Enzyme Inhibitors Nevi and Melanomas Protein Kinase Inhibitors Pharmacologic Actions |