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Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

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ClinicalTrials.gov Identifier: NCT01183065
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
New York University Cancer Institute
NYU Langone Health
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Drug: Pralatrexate With Vitamin B12 and Folic Acid
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pralatrexate and Vitamin Supplementation
Hide Arm/Group Description

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Patient no longer fits eligibility crite             1
Arm/Group Title Pralatrexate and Vitamin Supplementation
Hide Arm/Group Description

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  76.9%
>=65 years
3
  23.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
1.Primary Outcome
Title To Determine the Overall Response Rate (CR+PR)
Hide Description by RECIST version 1.1 criteria
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate and Vitamin Supplementation
Hide Arm/Group Description:

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pralatrexate and Vitamin Supplementation
Hide Arm/Group Description

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.

All-Cause Mortality
Pralatrexate and Vitamin Supplementation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pralatrexate and Vitamin Supplementation
Affected / at Risk (%) # Events
Total   8/12 (66.67%)    
Gastrointestinal disorders   
Mucositis oral  2/12 (16.67%)  2
Vomiting  1/12 (8.33%)  1
General disorders   
Fatigue  1/12 (8.33%)  1
Death NOS  4/12 (33.33%)  4
Injury, poisoning and procedural complications   
Injury/poison & proced complications Other, spec  1/12 (8.33%)  1
Investigations   
Neutrophil count decreased  1/12 (8.33%)  1
Nervous system disorders   
Depressed level of consciousness  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/12 (8.33%)  1
Aspiration  1/12 (8.33%)  1
Dyspnea  1/12 (8.33%)  1
Stridor  1/12 (8.33%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pralatrexate and Vitamin Supplementation
Affected / at Risk (%) # Events
Total   8/12 (66.67%)    
Gastrointestinal disorders   
Dry mouth  1/12 (8.33%)  1
Dysphagia  2/12 (16.67%)  2
Mucositis oral  4/12 (33.33%)  4
Nausea  2/12 (16.67%)  2
Oral pain  1/12 (8.33%)  1
Vomiting  1/12 (8.33%)  2
General disorders   
Fatigue  3/12 (25.00%)  3
Infections and infestations   
Mucosal infection  1/12 (8.33%)  1
Investigations   
Alkaline phosphatase increased  1/12 (8.33%)  3
Aspartate aminotransferase increased  1/12 (8.33%)  1
Lymphocyte count decreased  3/12 (25.00%)  5
Neutrophil count decreased  1/12 (8.33%)  1
Platelet count decreased  1/12 (8.33%)  1
Weight loss  2/12 (16.67%)  2
White blood cell decreased  2/12 (16.67%)  2
Metabolism and nutrition disorders   
Anorexia  1/12 (8.33%)  1
Hyperglycemia  2/12 (16.67%)  3
Hyponatremia  1/12 (8.33%)  1
Hypophosphatemia  1/12 (8.33%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1/12 (8.33%)  2
Chest wall pain  1/12 (8.33%)  2
Nervous system disorders   
Headache  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1/12 (8.33%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ho, Alan, MD, PhD (Assistant Attending)
Organization: Memorial Sloan Kettering Cancer Center
Phone: +1646-888-4235
EMail: HoA@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01183065     History of Changes
Other Study ID Numbers: 10-112
First Submitted: August 11, 2010
First Posted: August 17, 2010
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015