Azacitidine and Recombinant Interferon Alfa-2b in Treating Patients With Stage III or Stage IV Melanoma or Stage IV Kidney Cancer That Cannot Be Removed By Surgery

NCT00217542 | Completed Phase 1

• 5 other identifiers: NCI-2009-00152YALE HIC#27409YALE-HIC-27409NCI-7317CDR0000441640
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of recombinant interferon alfa-2b when given together with azacitidine in treating patients with stage III or stage IV melanoma or stage IV kidney cancer that cannot be removed by surgery. 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. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving azacitidine together with recombinant interferon alfa-2b may kill more tumor cells.

Conditions

Recurrent Melanoma; Recurrent Renal Cell Cancer; Stage III Melanoma; Stage IV Melanoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (3)

• Adverse event profile of azacitidine and recombinant interferon alfa-2b in patients with unresectable or metastatic melanoma and renal cell carcinoma

  Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  Continuously throughout study

• Maximum tolerated dose of recombinant interferon alfa-2b when administered in combination with 5-azacitidine

  Toxicity will be graded according to the NCI CTCAE version 3.0. The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle DLT.

  Course 1 (4 weeks)

• Correlation of promoter methylation with the level of expression of the genes

  Determined by Western blotting, immunohistochemistry, and/or RT-PCR. We will use Western blot analysis when antibodies are available and semi-quantitative RT-PCR in cases where antibodies are not available.

  Day 5 or 8 and 24 or 26 of course 1

Secondary Outcomes (1)

• Response rate of giving recombinant interferon alfa-2b when administered in combination with 5-azacitidine in patients with metastatic melanoma and renal cell carcinoma

  Every 8 weeks

Study Arms (1)

Treatment (chemotherapy, biological therapy)

EXPERIMENTAL

Patients receive azacitidine SC once daily on days 1-4 and 15-17 and recombinant interferon alfa-2b SC on days 8, 10, 12, 15, 17, 19, 22, 24, and 26 during course 1. Beginning in course 2 and for all subsequent courses, patients receive azacitidine SC once daily on days 1-3 and 15-17 and interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 12 total courses in the absence of disease progression or unacceptable toxicity.

Biological: recombinant interferon alfa-2b; Drug: amifostine/azacitidine

Interventions

recombinant interferon alfa-2b BIOLOGICAL

Given SC

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Intron A

Treatment (chemotherapy, biological therapy)

amifostine/azacitidine DRUG

Given SC

Treatment (chemotherapy, biological therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of 1 of the following:
• Melanoma
• Unresectable stage III disease
• Stage IV disease
• Renal cell carcinoma
• Unresectable and/or stage IV disease
• Measurable disease
• No untreated brain metastases or leptomeningeal disease
• Patients with previously treated brain metastases are eligible provided they have no evidence of progression for ≥ 4 weeks following treatment and do not require steroids
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520-8032, United States

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell

Interventions

Introns; Amifostine; Azacitidine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Mario Sznol

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2005
• Primary Completion: July 1, 2008
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)