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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00746746
• Other study ID #: USA-MCI-01
• Secondary ID: IND# 13647
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 3, 2008
• Last updated: January 12, 2011
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2008
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.

Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 19 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• HyperAcute vaccine
1.8 mL weekly

Drug:
• Pegylated Interferon-Alpha 2b
6.0 mcg/kg weekly

Locations

Country	Name	City	State
United States	Ochsner Health System	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   Ochsner Health System website