Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398450
First received: November 9, 2006
Last updated: February 6, 2009
Last verified: January 2007
  Purpose

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 Intervention Phase
Melanoma (Skin)
Biological: recombinant interferon alfa-2b
Drug: azacitidine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Survival at day 1, 12 months, 3 years, and 5 years [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
  • Time to relapse [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: February 2006
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398450

Locations
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
Investigators
Principal Investigator: Gregory A. Daniels, MD, PhD University of California, San Diego
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00398450     History of Changes
Other Study ID Numbers: CDR0000511743, UCSD-060199, PHARMION-UCSD-060199
Study First Received: November 9, 2006
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 01, 2014