Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- 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) |
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 |
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| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| 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 Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Reaferon Azacitidine Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 22, 2013