Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma

NCT00383851 | Unknown Phase 2

• 1 other identifier: ATN-224-008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 17

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.

Conditions

Melanoma

Keywords

ATN-224; Temozolomide; Combination; Sequential; Anti-angiogenic; Copper

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Interventions

ATN-224 DRUG

Temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Attenuon: lead

Study Sites (17)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Pacific Oncology and Hematology

Encinitas, California, 92024, United States

Location

Hematology - Oncology Group of Orange, Inc.

Orange, California, 92868, United States

Location

UCI Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

The Angeles Clinic

Santa Monica, California, 90404, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80262, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Hematology and Oncology Specialists, LLC

Metairie, Louisiana, 70006, United States

Location

The Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Mountainside Hospital Cancer Center - The Melanoma Center

Montclair, New Jersey, 07042, United States

Location

Oncology Hematology Care

Cincinati, Ohio, 45242, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

tetrathiomolybdate; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilad Gordon, MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 4, 2006
• Study Start: September 1, 2006
• Study Completion: September 1, 2008
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

US (17)