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A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer (276)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01671488
Recruitment Status : Terminated (pilot data to be used for upcoming larger trial.)
First Posted : August 23, 2012
Results First Posted : May 12, 2017
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anal Cancer
Interventions Biological: Treatment
Drug: 5FU
Drug: Mitomycin
Radiation: IMRT
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started [1] 11
Completed 10
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
This is for patients who signed consent
Arm/Group Title Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  54.5%
>=65 years
5
  45.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
60.36
(37 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient's who received treatment on study
Arm/Group Title Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
2.Primary Outcome
Title To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.
Hide Description Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.
Time Frame Tumor evaluation 6 months after coming off study
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patient's who received treatment on study
Arm/Group Title Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
3.Secondary Outcome
Title To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.
Hide Description

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.

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
Hide Outcome Measure Data
Hide Analysis Population Description
As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS
Arm/Group Title Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
8
  88.9%
Time Frame SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Adverse Event Reporting Description

Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment.

The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.

 
Arm/Group Title Treatment
Hide Arm/Group Description

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.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   10/10 (100.00%)    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Investigations   
fever (1), hypotension(2)  1  1/10 (10.00%)  1
fever (1), hypotension(2) Hypokalemia (3)  1  1/10 (10.00%)  1
weakness (3), decreased appetite (2), GI bleed(3). Anemia(3)  1  1/10 (10.00%)  1
Nausea (3), dehydration (3), anal mucositis (3), enterocolitis (2)  1  1/10 (10.00%)  1
Nausea(3),dehydration(3),anal mucositis(3),  1 [1]  1/10 (10.00%)  1
Expired unknown reason (5)  1  1/10 (10.00%)  1
seizure (3), catastrophic pulmonary or cardiac event or massive CVA (5)  1  1/10 (10.00%)  1
PLT(4), diarrhea (2), ANC (3), fever (1)  1  1/10 (10.00%)  1
Diarrhea (3), dehydration(3), wt loss (2), back pain (2), fatigue (2),  1 [2]  1/10 (10.00%)  1
Diarrhea (2), wt loss (2) , back pain (1), fatigue (2),  1 [3]  1/10 (10.00%)  1
fever (1) headache (1)  1  1/10 (10.00%)  1
Fever(1*)febrile neutropenia(3*)ANC(3*)WBC (4*), PLT (4*)  1 [4]  1/10 (10.00%)  1
ANC (4*)WBC(4*)PLT(3*)Anemia (3*)cellulitis (2*),mucositis (1*)Lymph (4*),  1 [5]  1/10 (10.00%)  1
chest pain (1*), shortness of breath (3*), lightheadedness (1*)  1  1/10 (10.00%)  1
Rectal bleeding (3*), Anemia (2*) , ANC(3*) , PLT(4*) , Fever (1*)  1 [6]  1/10 (10.00%)  1
Rectal bleeding (3*)Anemia (3*)ANC(4*)PLT(4*)Fever (1*)  1 [7]  1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
enterocolitis(2),colitis(2),perianal pain(3), diarrhea(2),weakness(2),Anemia(2)
[2]
hypokalemia (3), HGB(3), PLT (2), Glucose (1), Hyponatremia (1), albumin(1), hypocalcemia (1), WBC (2), Lymph (4)
[3]
HGB(2), PLT (3), Glucose-hyperglycemia (1), , albumin(2), hypocalcemia (2), WBC (2), Lymph (2), fever (2)
[4]
Anemia (3*)cellulitis (2*)acute kidney injury(2*)creatinine(2*)mucositis(1*)Lymph(4*)
[5]
thromboembolic event(2*),left lower leg edema(1*)
[6]
Dermatitis radiation (3*) , pain rectal (2*)
[7]
Dermatitis radiation (3*)pain rectal (2*)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   8/10 (80.00%)    
Investigations   
allergies  1  2/10 (20.00%)  2
ALT  1  2/10 (20.00%)  2
anal mucositis  1  1/10 (10.00%)  1
ANC  1  2/10 (20.00%)  2
Anemia  1  3/10 (30.00%)  3
anorexia  1  2/10 (20.00%)  2
anxiety  1  1/10 (10.00%)  1
APTT  1  1/10 (10.00%)  1
AST  1  2/10 (20.00%)  2
chills/rigors  1  8/10 (80.00%)  8
constipation  1  2/10 (20.00%)  2
confusion  1  1/10 (10.00%)  1
creatinine  1  1/10 (10.00%)  1
Dehydration  1  2/10 (20.00%)  2
depression  1  2/10 (20.00%)  2
Diarrhea  1  5/10 (50.00%)  5
Frequent stools (non-diarrhea)  1  1/10 (10.00%)  1
fecal incontinence  1  2/10 (20.00%)  2
Dizziness  1  3/10 (30.00%)  3
dyspepsia  1  1/10 (10.00%)  1
Dyspnea/SOB  1  3/10 (30.00%)  3
edema  1  2/10 (20.00%)  2
erythoderma/erythema  1  1/10 (10.00%)  1
dry skin  1  1/10 (10.00%)  1
ejaculatory dysfunction  1  1/10 (10.00%)  1
epistaxis  1  1/10 (10.00%)  1
Fatigue  1  6/10 (60.00%)  6
fever  1  3/10 (30.00%)  3
flu-like symptoms  1  1/10 (10.00%)  1
gastritis  1  1/10 (10.00%)  1
GI bleed/bloody diarrhea/rectal bleed  1  1/10 (10.00%)  1
H/A  1  5/10 (50.00%)  5
hematuria  1  2/10 (20.00%)  2
Hot flashes  1  3/10 (30.00%)  3
Hyperpigmentation  1  2/10 (20.00%)  2
hyperglycemia  1  1/10 (10.00%)  1
Hypoalbumin  1  4/10 (40.00%)  4
Hypocalcemia  1  2/10 (20.00%)  2
hypohydrosis  1  1/10 (10.00%)  1
HypoK  1  5/10 (50.00%)  5
HypoMG  1  2/10 (20.00%)  2
Hyponatremia  1  8/10 (80.00%)  8
hypotension  1  1/10 (10.00%)  1
Hypertension  1  5/10 (50.00%)  5
INR  1  1/10 (10.00%)  1
Lightheadedness  1  1/10 (10.00%)  1
lymphocyte decrease  1  7/10 (70.00%)  7
migraine  1  1/10 (10.00%)  1
mucositis/mouth sores  1  8/10 (80.00%)  8
myalgia  1  2/10 (20.00%)  2
arthralgia  1  2/10 (20.00%)  2
nausea  1  7/10 (70.00%)  7
pain-abdomen  1  4/10 (40.00%)  4
pain/back and neck  1  3/10 (30.00%)  3
pain secondary to abcess/infection  1  1/10 (10.00%)  1
pain-epigastric  1  1/10 (10.00%)  1
pain-general  1  1/10 (10.00%)  1
pain-joints  1  1/10 (10.00%)  1
pain-leg  1  2/10 (20.00%)  2
rectal pain/perianal pain  1  5/10 (50.00%)  5
paresthesia  1  2/10 (20.00%)  2
PLT  1  5/10 (50.00%)  5
Radiation Dermatitis  1  4/10 (40.00%)  4
rash  1  1/10 (10.00%)  1
skin ulceration/Groin sore  1  3/10 (30.00%)  3
infection (cellulitis/small intestine, abscess, UTI, vaginal)  1  3/10 (30.00%)  3
social circumstances  1  1/10 (10.00%)  1
sore throat  1  1/10 (10.00%)  1
Tachycardia  1  1/10 (10.00%)  1
tooth infection  1  1/10 (10.00%)  1
urinary frequency  1  1/10 (10.00%)  1
urinary pain/dysuria  1  3/10 (30.00%)  3
urinary retention  1  1/10 (10.00%)  1
vomitng  1  3/10 (30.00%)  3
WBC  1  6/10 (60.00%)  6
weakness  1  1/10 (10.00%)  1
wt loss  1  3/10 (30.00%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Howard Safran, MD
Organization: Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
EMail: kayla_rosati@brown.edu
Layout table for additonal information
Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01671488    
Other Study ID Numbers: BrUOG 276
First Submitted: August 7, 2012
First Posted: August 23, 2012
Results First Submitted: December 13, 2016
Results First Posted: May 12, 2017
Last Update Posted: February 17, 2020