Clinical Trials Directory

Trials / Completed

CompletedNCT00023647

Vaccine Therapy in Treating Patients With Stage IV Melanoma

A Phase I Dose-Ranging Safety Study Using Intranodal Delivery of a Plasmid DNA (Synchrotope TA2M) in Adult Stage IV Melanoma Patients

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Mannkind Corporation · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given directly into a lymph node in treating patients who have stage IV melanoma.

Detailed description

OBJECTIVES: I. Determine the safety and tolerability of intranodal Synchrotope TA2M plasmid DNA vaccine in patients with stage IV melanoma. II. Determine the immune response of patients treated with this vaccine. III. Determine the clinical response of patients treated with this vaccine. OUTLINE: This is dose-escalation, multicenter study. Patients receive Synchrotope TA2M plasmid DNA vaccine intranodally continuously over 96 hours beginning on days 0, 14, 28, and 42. Treatment continues for up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 8 patients receive escalating doses of Synchrotope TA2M plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 8 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 16-24 patients will be accrued for this study within 12 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALSynchrotope TA2MCancer Vaccine, Immunotherapy
BIOLOGICALSynchrotope TA2MCancer Vaccine, Immunotherapy
BIOLOGICALSynchrotope TA2MCancer Vaccine, Immunotherapy

Timeline

Start date
2000-07-01
Primary completion
2002-04-01
Completion
2002-11-01
First posted
2004-02-16
Last updated
2012-07-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00023647. Inclusion in this directory is not an endorsement.