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Study 13 of 6485 for search of: | United States, Ohio |
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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00521001 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Giving everolimus together with temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: everolimus Drug: temozolomide Procedure: flow cytometry Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy for Metastatic Melanoma |
Estimated Enrollment: | 43 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA.
After completion of study treatment, patients are followed every 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unresectable stage IV malignant melanoma with measurable disease
PATIENT CHARACTERISTICS:
No serious medical condition that may make it unsafe for a patient to enroll in study, including any of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Ravi D. Rao, MD, MBBS | Mayo Clinic |
Investigator: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | William J. Maples, MD | Mayo Clinic |
Investigator: | Michael K. Gornet, MD | Mayo Clinic Hospital |
Investigator: | Edward T. Creagan, MD | Mayo Clinic |
Investigator: | Barbara A. Pockaj, MD | Mayo Clinic Hospital |
Investigator: | Judith S. Kaur, MD | Mayo Clinic |
Study ID Numbers: | CDR0000562166, NCCTG-N0675 |
Study First Received: | August 24, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00521001 |
Health Authority: | United States: Federal Government |
stage IV melanoma |
Everolimus Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Temozolomide Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |