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 - Full Text View

Sponsors and Collaborators:	University of South Alabama NewLink Genetics Corporation
Information provided by:	University of South Alabama
ClinicalTrials.gov Identifier:	NCT00746746

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 II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University of South Alabama:

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 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

1.8 mL weekly

6.0 mcg/kg weekly

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

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

Contacts

Contact: Marion Long, RN	251-665-8000	long@usouthal.edu
Contact: Pam Francisco, CCRP	251-665-8000	pfrancisco@usouthal.edu

Locations

United States, Alabama
University of South Alabama Mitchell Cancer Institute	Recruiting
Mobile, Alabama, United States, 36607
Contact: Marion Long, RN 251-665-8000 long@usouthal.edu
Contact: Pam Francisco, CCRP 251-665-8000 pfrancisco@usouthal.edu

Sponsors and Collaborators

University of South Alabama

NewLink Genetics Corporation

Investigators

Principal Investigator:

Adam I Riker, MD

USA Mitchell Cancer Institute

More Information

USA Mitchell Cancer Institute website This link exits the ClinicalTrials.gov site

Responsible Party:	USA Mitchell Cancer Institute ( Adam I. Riker, M.D. Chief, Surgical Oncology, Associate Professor of Surgery )
Study ID Numbers:	USA-MCI-01, IND# 13647
Study First Received:	September 3, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746746
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of South Alabama:

Advanced Melanoma

Study placed in the following topic categories:

Interferon-alpha
Interferon Type I, Recombinant
Interferons
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Nevus, Pigmented
Peginterferon alfa-2b
Neuroepithelioma
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009