Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398450
• Other study ID #: UCSD-060199
• Secondary ID: CDR0000511743PHA
• Status: Completed
• Phase: Phase 1
• Start date: February 2006
• Est. completion date: April 2010

Study information

• Verified date: March 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• recombinant interferon alfa-2b

Drug:
• azacitidine

Locations

Country	Name	City	State
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose
Primary	Toxicity
Secondary	Response
Secondary	Survival at day 1, 12 months, 3 years, and 5 years
Secondary	Relapse-free survival
Secondary	Time to relapse