Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Non-melanomatous Skin Cancer | Skin Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| LMB-2 immunotoxin | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective clinical response rate
Secondary outcomes (3)
- measure
- Changes in levels of CD4+, CD25+ regulatory T cells
- measure
- Ability of LMB-2 to augment peptide vaccination
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available