Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma

Status unconfirmed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00383851

Run by

Attenuon

People needed

60

Starts

2006-09-01

Expected to finish

2008-09-01

Last updated by the study team

2007-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with histologically confirmed, advanced cutaneous melanoma. Advanced melanoma is defined as locally advanced disease that is not amenable to surgery or radiation therapy and metastatic disease. Patients may have had adjuvant treatment for prior early disease as long as it was given at least 6 months before the first dose of study medication, and the treatment did not contain temozolomide or dacarbazine. Previous treatment for advanced disease is acceptable as long as the patient did not receive temozolomide or dacarbazine. There is no restriction on the number of prior regimens.
• Age ≥18 years
• Life expectancy of greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥50%; see Appendix A)
• Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count ≥1,500/uL
• platelets ≥100,000/uL
• hemoglobin ≥9 g/dL
• total bilirubin ≤2 X institutional upper limit of normal (ULN)
• AST(SGOT) and ALT(SGPT) ≤2 X ULN
• creatinine clearance (measured or calculated) ≥30 mL/min
• Patients are allowed to receive erythropoietin or blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to >9 g/dL to meet eligibility criteria.
• Use of adequate contraception. Temozolomide has the potential to cause fetal harm. The effects of ATN 224 on the developing human fetus at the recommended therapeutic dose are unknown, but antiangiogenic agents are known to be teratogenic. For these reasons women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of ATN 224 or temozolomide.
• Willingness to forgo taking copper- or zinc-containing vitamins or supplements
• Ability to understand and the willingness to sign a written informed consent document
• Uveal (ocular) melanoma
• Brain metastasis that has not been treated and remained stable for at least 4 weeks (In other words, patients are eligible if they have no metastases or if brain metastases have been treated and remain stable for at least 4 weeks)
• Patients may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ATN-224 or omeprazole
• History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 or temozolomide absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
• Ineligible to receive either temozolomide (Temodar®), omeprazole (Prilosec®), lansoprazole (Prevacid®), pantoprazole (Protonix®), or ranitidine (Zantac®)
• Inability to swallow study medication capsules
• Other serious medical or psychiatric illness preventing informed consent or with the potential to interfere with assessment of safety or efficacy of ATN-224 treatment
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients known to be positive for HIV or infectious hepatitis type A, B or C

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Pacific Oncology and Hematology — Encinitas, California, United States
• Hematology - Oncology Group of Orange, Inc. — Orange, California, United States
• UCI Chao Family Comprehensive Cancer Center — Orange, California, United States
• The Angeles Clinic — Santa Monica, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Hematology and Oncology Specialists, LLC — Metairie, Louisiana, United States
• The Harry and Jeanette Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, 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
• Cancer Center of the Carolinas — Greenville, South Carolina, United States
• Chattanooga Oncology and Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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