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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


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Adam I Riker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ochsner Health System

Authority:

United States: Food and Drug Administration

Study ID:

USA-MCI-01

NCT ID:

NCT00746746

Start Date:

June 2008

Completion Date:

June 2011

Related Keywords:

  • Melanoma
  • Advanced Melanoma
  • Melanoma

Name

Location

Ochsner Health SystemNew Orleans, Louisiana  70121