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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

Primary Purpose

Melanoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HyperAcute vaccine
Pegylated Interferon-Alpha 2b
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Advanced Melanoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ochsner Health System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2008
Last Updated
January 12, 2011
Sponsor
Ochsner Health System
Collaborators
NewLink Genetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00746746
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ochsner Health System
Collaborators
NewLink Genetics Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Advanced Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HyperAcute vaccine
Intervention Description
1.8 mL weekly
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon-Alpha 2b
Other Intervention Name(s)
PEG-Intron
Intervention Description
6.0 mcg/kg weekly
Primary Outcome Measure Information:
Title
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam I Riker, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ochsner.org
Description
Ochsner Health System website

Learn more about this trial

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

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