Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma - Full Text View

Sponsors and Collaborators:	University of California, San Diego National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00398450

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 I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Azacitidine Interferons

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Gregory A. Daniels, MD, PhD

University of California, San Diego

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Melanoma

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Azacitidine
Neuroepithelioma
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Azacitidine
Nevi and Melanomas
Angiogenesis Modulating Agents

Growth Inhibitors
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Enzyme Inhibitors
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on September 11, 2009