Back to resultsStudy of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pralatrexate With Vitamin B12 and Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Pralatrexate, Vitamin B12, Folic Acid, 10-112
Eligibility Criteria
Inclusion Criteria:
- Patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. Confirmation of biopsy/diagnosis will be performed at MSKCC or at participating sites (NYU Cancer Institute/NYU Medical Center/ Bellevue Hospital Center).
- Patients must be at least 18 years of age.
- ECOG performance status must be ≥ 0 or 1.
- Disease must be measurable by RECIST version 1.1 criteria.
- Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,.
- At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment.
- Patients must have adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) > 1,000 cells/mm3, platelets > 100,000 cells/mm3, and hemoglobin > 9 g/dL Hepatic: AST and ALT ≤ 3 X upper limit of normal (ULN); AST and ALT ≤ 5 X ULN if liver metastasis present; Total bilirubin ≤ 1.5 x ULN unless Gilbert's disease is present Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min
- Both women and men and members of all races and ethnic groups are eligible for this trial.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug.
Exclusion Criteria:
- History of any brain metastases unless resected with no evidence for > 12 weeks and not on steroids
- Women who are lactating
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
- Patients who have undergone an allogeneic stem cell transplant
Sites / Locations
- Memoral Sloan Kettering Cancer Center
- Memorial Sloan-Kettering Cancer Center @ Suffolk
- Memorial Sloan-Kettering Cancer Center
- Memorial Sloan-Kettering at Mercy Medical Center
- Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pralatrexate and vitamin supplementation
Arm Description
This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Outcomes
Primary Outcome Measures
To Determine the Overall Response Rate (CR+PR)
by RECIST version 1.1 criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT01183065
First Posted
August 11, 2010
Last Updated
October 19, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York University Cancer Institute, NYU Langone Health, National Comprehensive Cancer Network
1. Study Identification
Unique Protocol Identification Number
NCT01183065
Brief Title
Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Official Title
A Multi-Institution Phase II Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York University Cancer Institute, NYU Langone Health, National Comprehensive Cancer Network
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells.
Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Pralatrexate, Vitamin B12, Folic Acid, 10-112
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pralatrexate and vitamin supplementation
Arm Type
Experimental
Arm Description
This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Intervention Type
Drug
Intervention Name(s)
Pralatrexate With Vitamin B12 and Folic Acid
Other Intervention Name(s)
Radiologic assessment of disease will be conducted every 1.5 to 2 cycles (approximately, every 6 to 8 weeks); after 6 months, radiologic studies will be performed every 2.5 to 3, cycles (approximately every 10 to 12 weeks) of therapy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
To Determine the Overall Response Rate (CR+PR)
Description
by RECIST version 1.1 criteria
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. Confirmation of biopsy/diagnosis will be performed at MSKCC or at participating sites (NYU Cancer Institute/NYU Medical Center/ Bellevue Hospital Center).
Patients must be at least 18 years of age.
ECOG performance status must be ≥ 0 or 1.
Disease must be measurable by RECIST version 1.1 criteria.
Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,.
At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment.
Patients must have adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) > 1,000 cells/mm3, platelets > 100,000 cells/mm3, and hemoglobin > 9 g/dL Hepatic: AST and ALT ≤ 3 X upper limit of normal (ULN); AST and ALT ≤ 5 X ULN if liver metastasis present; Total bilirubin ≤ 1.5 x ULN unless Gilbert's disease is present Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min
Both women and men and members of all races and ethnic groups are eligible for this trial.
Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug.
Exclusion Criteria:
History of any brain metastases unless resected with no evidence for > 12 weeks and not on steroids
Women who are lactating
Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
Patients who have undergone an allogeneic stem cell transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Ho, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
City
Sleepy Hollow
State/Province
New York
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
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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