A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Gregory A. Daniels, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Federal Government
Study ID:
CDR0000511743
NCT ID:
NCT00398450
Start Date:
February 2006
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
