Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2010 |
| End Date: | April 2014 |
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)
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.
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.
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
We found this trial at
5
sites
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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