Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

NCT01183065 | Completed Phase 2 Results

• 1 other identifier: 10-112
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

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.

Conditions

Head and Neck Cancer

Keywords

Pralatrexate; Vitamin B12; Folic Acid; 10-112

Outcome Measures

Primary Outcomes (1)

• To Determine the Overall Response Rate (CR+PR)

  by RECIST version 1.1 criteria

  2 years

Study Arms (1)

pralatrexate and vitamin supplementation

EXPERIMENTAL

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

Drug: Pralatrexate With Vitamin B12 and Folic Acid

Interventions

Pralatrexate With Vitamin B12 and Folic Acid DRUG

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.

Also known as: 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.

pralatrexate and vitamin supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• New York University Cancer Institute: collaborator
• NYU Langone Health: collaborator
• National Comprehensive Cancer Network: collaborator

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

Sleepy Hollow, New York, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

10-propargyl-10-deazaaminopterin; Vitamin B 12; Folic Acid; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Ho, Alan, MD, PhD (Assistant Attending)
• Organization: Memorial Sloan Kettering Cancer Center

HoA@mskcc.org

+1646-888-4235

Study Officials

• Alan Ho, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (5)