Recombinant Interferon Alfa-2b in Treating Patients With Melanoma

NCT01460875 | Completed Results DMC

• 2 other identifiers: OSU-07033NCI-2011-03121
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma

Conditions

Stage IA Skin Melanoma; Stage IB Skin Melanoma; Stage IIA Skin Melanoma; Stage IIB Skin Melanoma; Stage IIC Skin Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma

Keywords

high risk melanoma; lymph node disease

Outcome Measures

Primary Outcomes (1)

• Level of Activated STAT1(Phospho-STAT1)

  Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.

  up to 4 weeks

Secondary Outcomes (7)

• Number of Patients With Adverse Events

  up to 1 year

• Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation

  Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months

• Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes

  1 hour post therapy

• Effect of Dose-reduction on Interferon Alfa Gene Expression

  1 hour post therapy

• Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69

  4 hours post therapy

Study Arms (1)

Treatment (interferon therapy)

EXPERIMENTAL

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

Biological: recombinant interferon alfa-2b; Other: laboratory biomarker analysis

Interventions

recombinant interferon alfa-2b BIOLOGICAL

Given SC

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

Treatment (interferon therapy)

laboratory biomarker analysis OTHER

Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Also known as: Correlative studies

Treatment (interferon therapy)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be considered a candidate for adjuvant IFN-alpha-2b therapy after having undergone successful surgery for high-risk melanoma (Breslow thickness \> 4 mm or lymph node disease) or complete resection of metastatic disease; definitive surgery should have been accomplished no greater than 90 days prior to start of treatment with intravenous IFN-alpha-2b
• Patients must have completed 20 treatments of intravenous IFN-alpha-2b according to standard practice within 2 months of beginning treatment on this study
• Patients must have not have any evidence of persistent or recurrent disease as determined by the appropriate radiologic imaging techniques
• Patients may have received prior IFN-alpha therapy for metastatic disease, but more than 6 months must have passed between the last dose of IFN-alpha therapy for metastatic disease and the first dose of intravenous IFN-alpha-2b; patients who have had prior interleukin (IL)-2 are eligible for this study
• Patients may have received radiation therapy after intravenous IFN-alpha-2b; they may begin subcutaneous dosing of IFN-alpha-2b on this study after the radiation therapy has been completed; the patient may initiate dose reductions after the last radiation treatment as long as the appropriate amount of time has passed
• Life expectancy of greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 70%)
• Leukocytes \>= 3,000/ul
• Absolute neutrophil count \>= 1,500/ul
• Platelets \>= 100,000/ul
• Total bilirubin =\< 2.0 (Gilbert's disease permitted)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) \< 3 x institutional upper limit of normal
• Creatinine =\< 1.5 and stable OR
• Creatinine clearance \>= 60 mL.min/1.73 m\^2 for patients with creatinine levels above normal
• Pulse oximetry \>= 90% on room air at rest

You may not qualify if:

• Patients may not be receiving any investigational agents
• History of allergic reactions attributed to compounds that are similar to interferon alpha-2b
• Patients known to be positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or hepatitis C antibody
• Patients with organ allografts or immunodeficiency syndromes
• Patients with prior malignancies may participate provided they have been free of disease for at least 2 years except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
• Pregnant women are excluded from this study because interferon alpha-2b is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IFN-alpha, breastfeeding should be discontinued if the mother is treated with IFN-alpha
• Prisoners will be excluded due to the need for multiple timed visits

Sponsors & Collaborators

• William Carson: lead
• Schering-Plough: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Melanoma

Interventions

Introns

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

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Results Point of Contact

• Title: William Carson, MD
• Organization: The Ohio State University Comprehensive Cancer Center

William.Carson@osumc.edu

614-293-6306

Study Officials

• William Carson, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: April 22, 2008
• Primary Completion: January 5, 2014
• Study Completion: January 5, 2014
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-10

Locations

US (1)