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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

Interventions

  • 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

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