CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
adenovirus-p53 transduced dendritic cell (DC) vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01042535
NCT01042535Phase 2Completed
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A Phase 1/2 Study of Ad.p53 DC Vaccine in Combination With 1-methyl-D-tryptophan in Metastatic Solid Tumors and Invasive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jan 5, 2010·Updated Apr 11, 2018

In Brief

A Phase 2 clinical trial evaluating adenovirus-p53 transduced dendritic cell (DC) vaccine, 1-methyl-d-tryptophan, and 1 other intervention for Male Breast Cancer and 3 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2010
Enrollment StartDec 28, 2009
Primary CompletionDec 1, 2014
Study CompletionFeb 27, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.5 years ago

Interventions

adenovirus-p53 transduced dendritic cell (DC) vaccinebiological

Given intradermally (ID)

1-methyl-d-tryptophandrug

Given orally (PO)

Laboratory biomarker analysisother

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