Head and Neck Cancer
Conditions
Keywords
Pralatrexate, Vitamin B12, Folic Acid, 10-112
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.
Interventions
DRUGPralatrexate 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.
Sponsors
New York University Cancer Institute
NYU Langone Health
National Comprehensive Cancer Network
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Overall Response Rate (CR+PR) | 2 years | by RECIST version 1.1 criteria |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient no longer fits eligibility crite | 1 |
Baseline characteristics
| Characteristic | Pralatrexate and Vitamin Supplementation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 12 |
| serious Total, serious adverse events | 8 / 12 |
Outcome results
Primary
To Determine the Overall Response Rate (CR+PR)
by RECIST version 1.1 criteria
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pralatrexate and Vitamin Supplementation | To Determine the Overall Response Rate (CR+PR) | 8 participants |