Status:
UNKNOWN
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
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
NewLink Genetics Corporation
Conditions:
Melanoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 (PE...
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 enginee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00746746
Start Date
June 1 2008
End Date
June 1 2011
Last Update
January 13 2011
Active Locations (1)
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1
Ochsner Health System
New Orleans, Louisiana, United States, 70121