NCT00004881

Vaccine Therapy in Treating Patients With Advanced Cancer

Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer.

Detailed description

OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in patients with MUC1 positive advanced cancer. II. Determine the biological and immunological effects of this regimen in this patient population. OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks, every other week for 8 weeks, and then every 4 weeks. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of TG4010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience treatment related grade 3 toxicity. If any patient experiences grade 4 toxicity, the prior dose level is considered the MTD. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	MVA-MUC1-IL2 vaccine

Timeline

• Start date: 2000-04-01
• Completion: 2004-05-01
• First posted: 2004-05-25
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States