Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

NCT ID: NCT00398450

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-04-30

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.

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
• Determine if the MTD of this regimen is biologically active in these patients.
• Define and describe the toxicities associated with this regimen.

Secondary

• Determine, preliminarily, the response in patients treated with this regimen.
• Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of azacitidine.

Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant interferon alfa-2b

Intervention Type: BIOLOGICAL

azacitidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Gregory Daniels

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory A. Daniels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Countries

United States

Other Identifiers

CDR0000511743

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHARMION-UCSD-060199

Identifier Type: -

Identifier Source: secondary_id

UCSD-060199

Identifier Type: -

Identifier Source: org_study_id