# iCAN-PREVENT: MD Anderson International Cancer Prevention Clinical Trial Consortium

> **NIH NIH UG1** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2020 · $1,814,563

## Abstract

Abstract
Cancer-related death is the second most common cause of death in the US, and the most
promising strategy to reduce cancer-related deaths and cancer incidence is through cancer
prevention. Previous clinical trials have demonstrated the feasibility of preventing cancer using
vaccines or cancer preventive drugs. However, the use of these agents is limited due to their
side effects. Clearly, safer and more effective cancer prevention interventions that are
acceptable to healthy individuals are urgently needed. Thus, the overarching goal of this
application is to bring a team of basic, translational, and clinical researchers together to identify
novel strategies to prevent cancer, test them in cancer prevention clinical trials, and ultimately
bring safe, efficacious, and acceptable preventive therapies to general use in individuals at high-
risk of this disease. To achieve this goal, we formed an international consortium (the iCAN-
PREVENT consortium) comprised of cancer prevention experts, clinical trialists, molecular
biologists, translational researchers, pathologists, statisticians, and bio-informatics experts, to
develop and conduct early phase cancer prevention trials. Our clinical research team has vast
experience in conducting both early and late phase clinical trials, and has conducted 18 Phase I
and II cancer prevention clinical trials through our previous chemoprevention clinical trial
consortia. Here, we propose two aims to test the hypothesis that we can conduct trials of drug
and vaccine therapies and demonstrate that these preventive therapies will safely modulate
critical tumor promoting pathways. Results from these early phase clinical trials will support the
advancement of these interventions to Phase III testing, and ultimately support the FDA-approval
of these interventions for cancer prevention. We will 1) conduct 5 to 10 early phase clinical trials
testing the safety and activity of a series of promising cancer prevention drugs, vaccines, and
immune modulating interventions in individuals at high-risk of cancer, and 2) develop and
implement novel methods to enhance recruitment and retention of patients in prevention trials
using social media, electronic news-blasts, and mobile messaging. To demonstrate our ability
to develop novel cancer prevention trials, we provide two sample trials: a Phase I trial of a novel
DNA-based vaccine encoding novel frameshift antigens that develop in individuals with Lynch
Syndrome, and a Phase II trial testing the ability of the mTOR inhibitor everolimus to alter breast
tissue biomarkers in individuals with prior triple-negative breast cancer. The results of these
early phase trials will advance cancer prevention drug development, and will ultimately help
reduce cancer incidence and mortality through prevention.

## Key facts

- **NIH application ID:** 9996650
- **Project number:** 5UG1CA242609-02
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** POWEL H BROWN
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,814,563
- **Award type:** 5
- **Project period:** 2019-08-15 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996650

## Citation

> US National Institutes of Health, RePORTER application 9996650, iCAN-PREVENT: MD Anderson International Cancer Prevention Clinical Trial Consortium (5UG1CA242609-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9996650. Licensed CC0.

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