Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 16 of 19 for:    pralatrexate AND PTCL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01183065
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
New York University Cancer Institute
NYU Langone Health
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE August 17, 2010
Results First Submitted Date  ICMJE October 19, 2015
Results First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
To Determine the Overall Response Rate (CR+PR) [ Time Frame: 2 years ]
by RECIST version 1.1 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01183065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
  • To determine the best overall response rate [ Time Frame: 2 years ]
    at the end of treatment with pralatrexate
  • To estimate median progression free survival (PFS). [ Time Frame: 2 years ]
  • To estimate median overall survival (OS). [ Time Frame: 2 years ]
  • To quantify the mRNA transcript levels of reduced folate carrier (RFC-1) [ Time Frame: 2 years ]
    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 ]
    and correlate to best overall response with pralatrexate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE 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:
  • 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.
Study Arms  ICMJE Experimental: pralatrexate and vitamin supplementation
This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Intervention: Drug: Pralatrexate With Vitamin B12 and Folic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
14
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01183065
Other Study ID Numbers  ICMJE 10-112
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • New York University Cancer Institute
  • NYU Langone Health
  • National Comprehensive Cancer Network
Investigators  ICMJE
Principal Investigator: Alan Ho, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP