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Phase II Study of Recombinant LMB-2 Immunotoxin and Peptide Vaccination Comprising gp100:209-217 (210M) Antigen, MART-1:27-35 Antigen, and Montanide ISA-51 in Patients With Progressive Unresectable Metastatic Melanoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II | Treatment | Completed | 18 and over | NCI-06-C-0041 7542, NCI-7542, NCI-P6702, NCT00295958 |
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.
Entry Criteria Disease Characteristics:
- Diagnosis of metastatic melanoma
- Unresectable disease
- Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine)
- HLA-A0201 positive
- Measurable disease
- The following are not allowed:
- Resectable local/regional disease
- Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2)
- Received LMB-2 on another trial
Prior/Concurrent Therapy:
- See Disease Characteristics
- More than 12 weeks since prior monoclonal antibody therapy
- More than 3 weeks since prior and no concurrent systemic therapy for cancer
- No concurrent chronic anticoagulant therapy
- No concurrent systemic steroid therapy
Patient Characteristics:
- ECOG performance status 0-2
- Life expectancy more than 3 months
- WBC ≥ 3,000/mm3
- Absolute lymphocyte count > 500/mm3
- Platelet count ≥ 90,000/mm3
- Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome)
- AST and ALT ≤ 2.5 times normal
- Albumin ≥ 3.0 g/dL
- No hepatitis B surface antigen or hepatitis C positivity
- Creatinine ≤ 1.4 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No ongoing or active infection
- Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease)
- LVEF ≥ 45%
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No known HIV positivity
- No autoimmune disease
- No immunodeficiency
- No other malignancies
- Must be willing to undergo leukapheresis
Expected Enrollment 26A total of 26 patients will be accrued for this study. Outcomes Primary Outcome(s)Objective clinical response rate
Secondary Outcome(s)Changes in levels of CD4+, CD25+ regulatory T cells Ability of LMB-2 to augment peptide vaccination Toxicity
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.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research | | | Steven Rosenberg, MD, PhD, Protocol chair | | | |
Registry Information | | Official Title | | Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma | | Trial Start Date | | 2005-12-07 | | Trial Completion Date | | 2008-04-22 | | Registered in ClinicalTrials.gov | | NCT00295958 | | Date Submitted to PDQ | | 2005-12-01 | | Information Last Verified | | 2007-10-04 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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