Status:
COMPLETED
Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
New York University Cancer Institute
NYU Langone Health
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01183065
Start Date
August 1 2010
End Date
April 1 2014
Last Update
November 20 2015
Active Locations (5)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States