Status:
COMPLETED
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. ...
Detailed Description
OBJECTIVES: Primary * Determine objective clinical response in patients with progressive, unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprisi...
Eligibility Criteria
Inclusion
- 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
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy more than 3 months
- WBC ≥ 3,000/mm\^3
- Absolute lymphocyte count \> 500/mm\^3
- Platelet count ≥ 90,000/mm\^3
- 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
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00295958
Start Date
December 1 2005
End Date
July 1 2008
Last Update
June 14 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201