Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
New York University Cancer Institute
New York University School of Medicine
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01183065
First received: August 11, 2010
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: Pralatrexate With Vitamin B12 and Folic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Drug Information available for:
Folic acid
Cyanocobalamin
Vitamin B Complex
Hydroxocobalamin
Pralatrexate
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- To determine the overall response rate (CR+PR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]by RECIST version 1.1 criteria
Secondary Outcome Measures:
- To determine the best overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]at the end of treatment with pralatrexate
- To estimate median progression free survival (PFS). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To estimate median overall survival (OS). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To quantify the mRNA transcript levels of reduced folate carrier (RFC-1) [ Time Frame: 2 years ] [ Designated as safety issue: No ]in study patients and correlate to best overall response with pralatrexate.
- To evaluate the impact of pralatrexate on circulating endothelial cells (CECs) and circulating progenitor cells (CPCs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]and correlate to best overall response with pralatrexate.
| Estimated Enrollment: | 14 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pralatrexate and vitamin supplementation
This will be an open-label, single arm, Simon optimal two-stage design phase II study.
|
Drug: 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183065
Locations
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | |
| Commack, New York, United States, 11725 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Memorial Sloan-Kettering at Mercy Medical Center | |
| Rockville Centre, New York, United States | |
| Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital | |
| Sleepy Hollow, New York, United States | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York University Cancer Institute
New York University School of Medicine
National Comprehensive Cancer Network
Investigators
| Principal Investigator: | Alan Ho, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01183065 History of Changes |
| Other Study ID Numbers: | 10-112 |
| Study First Received: | August 11, 2010 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Pralatrexate Vitamin B12 Folic Acid 10-112 |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Neoplasms, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Folic Acid Vitamin B Complex Vitamin B 12 Hydroxocobalamin |
Hematinics Vitamins Aminopterin Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents Therapeutic Uses Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013