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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00521001 |
Purpose
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 Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry Other: immunohistochemistry staining method Other: immunologic technique |
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.
Eligibility| 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:
Contacts and Locations
Show 199 Study Locations| 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 |
More Information
| Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
| Study ID Numbers: | CDR0000562166, NCCTG-N0675 |
| Study First Received: | August 24, 2007 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00521001 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma |
|
Everolimus Immunologic Factors Temozolomide Immunosuppressive Agents Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Antineoplastic Agents, Alkylating Alkylating Agents |
|
Everolimus Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Immunosuppressive Agents Temozolomide Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |