LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00295958|
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Non-melanomatous Skin Cancer||Biological: LMB-2 immunotoxin Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma|
|Study Start Date :||December 2005|
|Primary Completion Date :||June 2006|
|Study Completion Date :||July 2008|
- Objective clinical response rate
- Changes in levels of CD4+, CD25+ regulatory T cells
- Ability of LMB-2 to augment peptide vaccination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295958
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892-1201|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|