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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)

This study has been completed.
Sponsor:
Collaborators:
New York University Cancer Institute
New York University School of Medicine
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01183065
First received: August 11, 2010
Last updated: October 19, 2015
Last verified: October 2015
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Intervention: Drug: Pralatrexate With Vitamin B12 and Folic Acid

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pralatrexate and Vitamin Supplementation

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.


Participant Flow:   Overall Study
    Pralatrexate and Vitamin Supplementation
STARTED   13 
COMPLETED   12 
NOT COMPLETED   1 
Patient no longer fits eligibility crite                1 



  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
Pralatrexate and Vitamin Supplementation

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.


Baseline Measures
   Pralatrexate and Vitamin Supplementation 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   3 
Gender 
[Units: Participants]
 
Female   4 
Male   9 


  Outcome Measures

1.  Primary:   To Determine the Overall Response Rate (CR+PR)   [ Time Frame: 2 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ho, Alan, MD, PhD (Assistant Attending)
Organization: Memorial Sloan Kettering Cancer Center
phone: +1646-888-4235
e-mail: HoA@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01183065     History of Changes
Other Study ID Numbers: 10-112
Study First Received: August 11, 2010
Results First Received: October 19, 2015
Last Updated: October 19, 2015
Health Authority: United States: Institutional Review Board