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IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial


Phase 1/Phase 2
21 Years
75 Years
Open (Enrolling)
Both
Malignant Melanoma Stage III, Malignant Melanoma Stage IV

Thank you

Trial Information

IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial


IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a
very important role in cancer immunotherapy. A desirable property for a dendritic cell
vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated
antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have
shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+
T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved
immunotherapy product.


Inclusion Criteria:



- HLA A201 + phenotype

- Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease
at study entry

- Age: 21-75 years

- ECOG performance status 0-1

- Adequate marrow function

- Adequate hepatic function

- Adequate renal function

- Written informed consent

Exclusion Criteria:

- Subjects with measureable non-resectable melanoma

- Subjects who have had chemotherapy less than 4 weeks before starting trial

- Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial

- Subjects who received IL2 less than 4 weeks before starting trial

- Subjects with a baseline LDH greater than 1.1 times the ULN

- Subjects who are HIV positive

- Female subjects who are pregnant

- Subjects who have received corticosteroids or other immunosuppressive agents less
than 4 weeks before starting trial

- Subjects who have asthma and/or are on treatment for asthma

- Subjects with angina pectoris

- Subjects with congestive heart failure

- Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or
thyroiditis

- Subjects with active infections including viral hepatitis

- Subjects with a history of neoplastic disease othe than melanoma within the last 5
years

- History of neoplastic disease within the last 5 years except for carcinoma in situ of
the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.

- Subjects who present with open wounds

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immune response

Outcome Time Frame:

14 weeks

Safety Issue:

No

Principal Investigator

Joseph Fay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System

Authority:

United States: Food and Drug Administration

Study ID:

009-273

NCT ID:

NCT01189383

Start Date:

January 2011

Completion Date:

September 2014

Related Keywords:

  • Malignant Melanoma Stage III
  • Malignant Melanoma Stage IV
  • Melanoma
  • Vaccine
  • Dendritic Cell
  • Immune response
  • Safety
  • Efficacy
  • Melanoma

Name

Location

Baylor University Medical CenterDallas, Texas  75246