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A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

NCT01671488 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-02-17

Study results available
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Summary

The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an investigational agent that is not approved by the FDA to treat anal cancer or any other cancer.

Conditions

Interventions

BIOLOGICAL

Treatment

ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.

DRUG

5FU

1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days

DRUG

Mitomycin

10 mg/m2, day 1 and 29 (day 29 can be + 7 days)

RADIATION

IMRT

54 Gy in 30 fractions at 1.8 Gy per fraction.

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Howard Safran, MD · Brown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671488 on ClinicalTrials.gov