NCT00295958

LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery

Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal cells. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * Determine objective clinical response in patients with progressive, unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100:209-217 (210M) antigen, MART-1:27-35 antigen, and Montanide ISA-51. Secondary * Determine changes in levels of CD4+, CD25+ regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen. * Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients. * Determine the toxicity profile of this regimen in these patients. OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3. Patients then receive peptide vaccinations comprising gp100:209-217 (210M) antigen emulsified in Montanide ISA-51 subcutaneously (SC), and MART-1:27-35 vaccine emulsified in Montanide ISA-51 SC on days 4, 5, 6, and 24-27 (course 1). After week 8, patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically in the absence of disease progression. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Conditions

• Melanoma (Skin)
• Non-melanomatous Skin Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LMB-2 immunotoxin
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	gp100 antigen
BIOLOGICAL	incomplete Freund's adjuvant

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-06-01
• Completion: 2008-07-01
• First posted: 2006-02-24
• Last updated: 2012-06-14

Locations

2 sites across 1 country: United States