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Trial record 1 of 2 for:    anal cancer | United States, Rhode Island
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A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer (276)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01671488
First received: August 7, 2012
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: December 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Anal Cancer
Interventions: Biological: Treatment
Drug: 5FU
Drug: Mitomycin
Radiation: IMRT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment

The first dose will be given 10-14 days prior to the initiation of chemoradiation.

Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.

The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.

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.

5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days

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

IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.


Participant Flow:   Overall Study
    Treatment
STARTED [1]   11 
COMPLETED   10 
NOT COMPLETED   1 
Withdrawal by Subject                1 
[1] This is for patients who signed consent



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

The first dose will be given 10-14 days prior to the initiation of chemoradiation.

Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.

The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.

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.

5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days

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

IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  54.5% 
>=65 years      5  45.5% 
Age 
[Units: Years]
Mean (Full Range)
 60.36 
 (37 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  54.5% 
Male      5  45.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      11 100.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures
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1.  Primary:   To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.   [ Time Frame: 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. ]

2.  Primary:   To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.   [ Time Frame: Tumor evaluation 6 months after coming off study ]

3.  Secondary:   To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard Safran, MD
Organization: Brown University Oncology Research Group (BrUOG)
phone: 4018633000
e-mail: kayla_rosati@brown.edu



Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01671488     History of Changes
Other Study ID Numbers: BrUOG 276
Study First Received: August 7, 2012
Results First Received: December 13, 2016
Last Updated: April 4, 2017