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Study of Ad.p53 DC Vaccine and 1-MTin Metastatic Invasive Breast Cancer

2014-08-27 03:16:53 | BioPortfolio

Summary

The purpose of this study is twofold. The first objective is to find the highest dose of 1-Methyl-D-tryptophan (shortened to 1-MT) combined with a vaccine called Ad.p53 DC that can be given safely to patients without causing severe side effects. The second objective is to see if 1-MT can help patients mount a better immune response to the Ad.p53 DC vaccine. Both of these treatments are experimental at this time.

Description

The dose of 1-MT that patients take will vary depending on when they enroll in this study. This study initially studies how increasing amounts of the drug combined with vaccine affects the patient's body. The starting dose is 100 mg and will be increased in a step-wise fashion (200mg, 400mg, and 600mg) in order to find out what is the most effective dose without any major side effects. If the drug is safe and well tolerated in the starting dose group, then it will be increased for the next group of patients who are enrolled on the trial. The information obtained from the dose escalation part of the study (safety, immune responses) will be used to select one of these four doses of 1-MT to combine with the Ad.p53 DC vaccine. This is the Phase 1 part of the study. The Phase 2 part of the trial will enroll patients at the selected dose of 1-MT plus the Ad.p53 DC vaccine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

Ad.p53 DC vaccine, 1-methyl-D-tryptophan (1-MT)

Location

H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
United States
33612

Status

Recruiting

Source

H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:53-0400

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