Trial · NCT01671488

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

NCT01671488, Phase 1, Phase 2, Terminated, Brown University; results first posted 2017-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer. Trials, record NCT01671488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01671488

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer
NCT number: NCT01671488
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 11 participants, actual
Lead sponsor: Brown University
Conditions: Anal Cancer
Interventions: Treatment, 5FU, Mitomycin, IMRT
First posted: 2012-08-23
Last updated: 2020-02-17
Results first posted: 2017-05-12

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.	Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.	Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.
Primary	To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.	Tumor evaluation 6 months after coming off study	Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.
Secondary	To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.	Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 years	Patients terminating study treatment early prior to disease recurrence will be followed every 6 months for year 1 then annually for a total of 5 years. The follow-up portion will commence once patient comes off study or post the 2-6 week post the 4th treatment time point/visit. Assessments were tumor evaluation via sigmoidoscopy, proctoscopy, colonoscopy or anoscope and also chest/abdomen/pelvic imaging.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.	Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.	Patient's who received treatment on study	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.	Tumor evaluation 6 months after coming off study	Number of patient's who received treatment on study	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.	Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 years	As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.	Treatment	10	Participants
To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.	Treatment	9	Participants
To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.	Treatment	8	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment	11
Overall Study	COMPLETED	Treatment	10
Overall Study	NOT COMPLETED	Treatment	1

Source ClinicalTrials.gov

Adverse events93

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	allergies	Investigations	Treatment	2	10	2
other	ALT	Investigations	Treatment	2	10	2
other	anal mucositis	Investigations	Treatment	1	10	1
other	ANC	Investigations	Treatment	2	10	2
other	Anemia	Investigations	Treatment	3	10	3
other	anorexia	Investigations	Treatment	2	10	2
other	anxiety	Investigations	Treatment	1	10	1
other	APTT	Investigations	Treatment	1	10	1
other	AST	Investigations	Treatment	2	10	2
other	chills/rigors	Investigations	Treatment	8	10	8

1 to 10 of 93Source ClinicalTrials.gov

See all 93 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	10	10
Total, other adverse events	Treatment	8	10
Total, serious adverse events	Treatment	10	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01671488

GET https://conductscience.org/api/trials/v1/NCT01671488/events?page=2

API reference For AI assistants