Vaccine Therapy in Treating Patients With Stage IV Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)
• Interventions: Biological: Synchrotope TA2M

• Registration Number: NCT00023647
• Lead Sponsor: Mannkind Corporation

Brief 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.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2001-09-13
• Primary Completion: 2002-04
• Study Completion: 2002-11
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synchrotope TA2M, 200 micrograms	Synchrotope TA2M	Tyrosinase peptides, 200 micrograms
Synchrotope TA2M, 800 micrograms	Synchrotope TA2M	Tyrosinase peptides, 800 micrograms
Synchrotope TA2M, 400 micrograms	Synchrotope TA2M	Tyrosinase peptides, 400 micrograms

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events assessed by complete blood count, blood chemistry, polymerase chain reaction, physical examination and urinalysis	Individual 96-hour infusion periods on days 0, 14, 28 and 42 and on day 56

Secondary Outcome Measures

Name	Time	Method
Change in magnitude of antigen-specific cytotoxic t-lymphocyte in peripheral blood mononuclear cells	Day 0 (pre-study), last day of individual 96-hour infusion periods (days 4, 17, 31 and 45) and on day 56
Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection	Days 1, 29 and 57
Change in size of target lesions by x-ray computed tomography before (day 0) and after (day 56)treatment	Change from pre-study (day 0) to day 56

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States