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

Ochsner Health System

Status and phase

Unknown

Phase 2

Conditions

Melanoma

Treatments

Biological: HyperAcute vaccine

Drug: Pegylated Interferon-Alpha 2b

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00746746

IND# 13647

USA-MCI-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No 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.