Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma
- Conditions
- Melanoma
- Registration Number
- NCT00383851
- Lead Sponsor
- Attenuon
- Brief Summary
This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment.
- Detailed Description
According to the National Cancer Institute PDQ database, advanced melanoma is refractory to most standard systemic therapy, and all newly diagnosed patients should be considered candidates for clinical trials. Although advanced melanoma is relatively resistant to therapy, several biologic response modifiers and cytotoxic agents have been reported to produce objective responses. Once melanoma is metastatic, treatments are palliative rather than curative. In spite of many attempts at multimodality therapy, the prognosis in this disease remains poor. Further agents are needed if progress is to be made with melanoma treatment.
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines. Clinical studies with a similar agent (ammonium tetrathiomolybdate) indicate that the agent can be administered continuously on a daily basis for years in some patients. ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways. Temozolomide, a commonly used agent for melanoma, also has a tolerable profile.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 24-week progression-free survival of the combination of temozolomide with ATN 224 and of temozolomide alone Evaluate the safety of ATN-224 in combination with or following temozolomide
- Secondary Outcome Measures
Name Time Method Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with the combination of ATN 224 and temozolomide Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with temozolomide alone Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with ATN 224 alone after progression of disease on temozolomide Time to treatment failure by progression of disease or death for patients receiving ATN 224 plus temozolomide and for patients receiving temozolomide followed by ATN 224 Explore blood and tumor biomarkers with the potential to correlate with activity
Trial Locations
- Locations (17)
Cancer Center of the Carolinas
🇺🇸Greenville, South Carolina, United States
Hematology and Oncology Specialists, LLC
🇺🇸Metairie, Louisiana, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Chattanooga Oncology and Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
University of Colorado Health Science Center
🇺🇸Denver, Colorado, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
UCI Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
The Angeles Clinic
🇺🇸Santa Monica, California, United States
Hematology - Oncology Group of Orange, Inc.
🇺🇸Orange, California, United States
Pacific Oncology and Hematology
🇺🇸Encinitas, California, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Mountainside Hospital Cancer Center - The Melanoma Center
🇺🇸Montclair, New Jersey, United States
Oncology Hematology Care
🇺🇸Cincinati, Ohio, United States