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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)

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

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)

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

- 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

- 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

- Both women and men and members of all races and ethnic groups are eligible for this

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate (CR+PR)

Outcome Description:

by RECIST version 1.1 criteria

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Alan Ho, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Head and Neck Cancer
  • Pralatrexate
  • Vitamin B12
  • Folic Acid
  • 10-112
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital Sleepy Hollow, New York  
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York