Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398450
Recruitment Status : Unknown
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 10, 2006
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: recombinant interferon alfa-2b Drug: azacitidine Phase 1

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
Study Start Date : February 2006
Estimated Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Maximum tolerated dose
  2. Toxicity

Secondary Outcome Measures :
  1. Response
  2. Survival at day 1, 12 months, 3 years, and 5 years
  3. Relapse-free survival
  4. Time to relapse

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398450

United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Sponsors and Collaborators
University of California, San Diego
National Cancer Institute (NCI)
Principal Investigator: Gregory A. Daniels, MD, PhD University of California, San Diego Identifier: NCT00398450     History of Changes
Other Study ID Numbers: CDR0000511743
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: January 2007

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs