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
Recruitment status was Active, not recruiting
Sponsor:
Ochsner Health System
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
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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:
Drug Information available for:
Interferon
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon Alfa-2b
U.S. FDA Resources
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:
Detailed Description:
-
Biological: HyperAcute vaccine
1.8 mL weekly
Drug: Pegylated Interferon-Alpha 2b
6.0 mcg/kg weekly
Other Name: PEG-Intron
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
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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Peginterferon alfa-2b Reaferon |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013