Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
NCT00658892CI-TRIAL-00027807completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B7-DC cross-linking antibody rHIgM12B7 | Biological | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Secondary outcomes (5)
- measure
- Progression free survival and overall survival time
- measure
- Toxicity
- measure
- Tumor response in terms of complete or partial response at 8 weeks
- measure
- Tetramer response
- measure
- Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage IV disease (M1a and M1b only) * Measurable disease according to RECIST criteria * HLA-A2 positive * Must have IgA in serum (any concentration) * No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 * AST ≤ 5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to provide informed consent * Agrees to return to Mayo Clinic Rochester for follow-up * Agrees to participate in the mandatory translational research component of the study * No uncontrolled or current infection * No known immune deficiency * No B or AB blood grouping PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior biologic therapy * No concurrent immunosuppressive therapy
References
Publications (0)
Data not yet available
No reference posted for this study.