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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Ochsner Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NewLink Genetics Corporation
Information provided by:
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00746746
First received: September 3, 2008
Last updated: January 12, 2011
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: HyperAcute vaccine
Drug: Pegylated Interferon-Alpha 2b
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: HyperAcute vaccine
    1.8 mL weekly
    Drug: Pegylated Interferon-Alpha 2b
    6.0 mcg/kg weekly
    Other Name: PEG-Intron
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746746

Locations
United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
NewLink Genetics Corporation
Investigators
Principal Investigator: Adam I Riker, MD Ochsner Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Adam I. Riker, M.D. Medical Director of Cancer Services, Ochsner Cancer Institute
ClinicalTrials.gov Identifier: NCT00746746     History of Changes
Other Study ID Numbers: USA-MCI-01, IND# 13647
Study First Received: September 3, 2008
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ochsner Health System:
Advanced Melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interferon-alpha
Interferons
Peginterferon alfa-2b
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014