A Phase 1 interventional study of recombinant vaccinia-B7.1 vaccine in Melanoma (Skin), sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
OBJECTIVES:
I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.
II. Determine all clinical toxicities associated with this regimen in this patient population.
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.
V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.
VII. Evaluate quality of life of these patients during this regimen.
OUTLINE: This is a dose escalation study.
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Patients must have one of the following as proof of prior vaccinia immunization:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Biological: recombinant vaccinia-B7.1 vaccine
This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)