A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma

NCT00746746 | Unknown Phase 2 DMC

• 2 other identifiers: USA-MCI-01IND# 13647
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.

Conditions

Melanoma

Keywords

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

• To conduct scientific studies of patient tumor and peripheral blood samples to determine the mechanism of any observed anti-tumor effect involving the immune responses to the HyperAcute® vaccine alone & combined with PEG-Intron

  2 years

Secondary Outcomes (1)

• To determine the safety and response rate of the administration of the HyperAcute®-Melanoma Vaccine combined with PEG-Intron® into patients with recurrent, refractory, metastatic, or high risk of recurrence melanoma

  2 years

Interventions

HyperAcute vaccine BIOLOGICAL

1.8 mL weekly

Pegylated Interferon-Alpha 2b DRUG

6.0 mcg/kg weekly

Also known as: PEG-Intron

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Histological diagnosis of melanoma
• AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, and N, M1), metastatic, progressive, refractory, recurrent or high risk of recurrence melanoma.
• Expected survival of more than 6 months
• Adequate organ function
• Measurable or non-measurable disease
• Must have negative serologies for Hepatitis B and C and HIV prior to entering study
• Must be more than 4 weeks since major surgery, radiotherapy, chemotherapy or biotherapy/targeted therapies
• Male and female subjects of child producing potential must agree to use contraception or avoidance pregnancy measures while enrolled on the study and for one month after the last immunization.

You may not qualify if:

• Active CNS metastases or carcinomatous meningitis
• Hypercalcemia
• Pregnant or nursing women
• Other malignancy within five years
• History of organ transplant or current active immunosuppressive therapy
• Subjects taking systemic corticosteroid therapy
• Active infection or antibiotics within 1-week prior to study
• Uncontrolled or significant congestive heart failure, myocardial infarction, ventricular arrhythmias or pulmonary dysfunction
• Autoimmune disease
• A known allergy to any component of the HyperAcute vaccine or PEG-Intron
• Patients having undergone splenectomy
• Patients with sickle-cell anemia or thalassemia major.

Sponsors & Collaborators

• Ochsner Health System: lead
• NewLink Genetics Corporation: collaborator

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Related Links

• Ochsner Health System website

MeSH Terms

Conditions

Melanoma

Interventions

peginterferon alfa-2b

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

Study Officials

• Adam I Riker, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: January 13, 2011

Record last verified: 2008-09

Locations

US (1)