IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

Sponsored by Baylor Research Institute

Phase Quota
Phase 1

The purpose of this study is to gather data on feasibility as well as immune and clinical efficacy of a dendritic cell vaccine using IL15 in patients with resected stage IIIc/IV melanoma

Study Start Date: January 2011

Estimated Completion Date: December 2016

Specialties: Internal Medicine: Infectious Disease Infectious Disease: Vaccine/Immunotherapy Allergy/Immunology: Vaccine/Immunotherapy Dermatology: Dermatologic Oncology


  • Biological: Autologous dendritic cells manufactured with GM-CSF, IL15 and loaded with melanoma/HIV peptides and KLH; then activated with LPS and CD40 Ligand
  • Biological: IL15-DC Vaccine

Inclusion criteria

  • HLA A201 + phenotype
  • Biopsy proven melanoma stages IIIc/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

Study Locations And Contact Information

  • Baylor University Medical Center, Dallas Texas

Feature this Clinical Trial

Get your trial in front of 1000s of physicians and patients.
Visit to find out how you can feature this clinical trial.