Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

NCT00398450 | Completed Phase 1 FDA Drug

• 3 other identifiers: UCSD-060199CDR0000511743PHARMION-UCSD-060199
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

• Toxicity

Secondary Outcomes (4)

• Response

• Survival at day 1, 12 months, 3 years, and 5 years

• Relapse-free survival

• Time to relapse

Interventions

recombinant interferon alfa-2b BIOLOGICAL

azacitidine DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * At least one lesion appropriate for 3 separate punch or core needle biopsies * Must have received and failed ≥ 1 prior systemic treatment for metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT \< 2 times ULN * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol * No uncontrolled infection * No known HIV positivity * No hepatitis B or hepatitis C infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior systemic therapy * More than 4 weeks since prior radiotherapy to target lesions with evidence of progression * No concurrent radiotherapy to target lesions * No concurrent oral or IV corticosteroids * Topical creams or ocular steroid drops are allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Introns; Azacitidine

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)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Gregory A. Daniels, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)