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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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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 CenterLa Jolla, California  92093-0658