A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma

NCT00118274 Phase 1/Phase 2 COMPLETED Results posted

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Details

Lead sponsor	Craig L Slingluff, Jr
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	170
Start date	2005-03
Completion	2010-02

Conditions

• Melanoma (Skin)

Interventions

• incomplete Freund's adjuvant
• melanoma helper peptide vaccine
• multi-epitope melanoma peptide vaccine
• tetanus toxoid helper peptide
• cyclophosphamide

Primary outcomes

• Safety of the Peptide Vaccines — 30 days after receiving the last dose of study drug, up to week 52
  Number of participants with dose-limiting toxicities

Countries

United States