Head and Neck CancerPhase 2NCT01183065
Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
A Phase 2 study testing Pralatrexate With Vitamin B12 and Folic Acid in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pralatrexate With Vitamin B12 and Folic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York
About this study
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)
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
- Being tested
- Pralatrexate With Vitamin B12 and Folic Acid
- Keywords
- Pralatrexate, Vitamin B12, Folic Acid, 10-112
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pralatrexate With Vitamin B12 and Folic AcidDrug
Also called 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| pralatrexate and vitamin supplementation | Experimental | This will be an open-label, single arm, Simon optimal two-stage design phase II study. Receives: Drug: Pralatrexate With Vitamin B12 and Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Overall Response Rate (CR+PR)
by RECIST version 1.1 criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York University Cancer Institute, NYU Langone Health, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Alan Ho, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183065
- Sponsor's protocol ID
- 10-112
- Status last verified
- Oct 2015
- First submitted
- 11 Aug 2010
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01183065
- Acronym / sponsor ID
- 10-112
- Conditions
- Head and Neck Cancer
- Keywords
- Pralatrexate, Vitamin B12, Folic Acid, 10-112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York University Cancer Institute, NYU Langone Health, National Comprehensive Cancer Network
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pralatrexate and vitamin supplementation | Experimental | Drug: Pralatrexate With Vitamin B12 and Folic AcidThis will be an open-label, single arm, Simon optimal two-stage design phase II study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pralatrexate With Vitamin B12 and Folic AcidAlso: 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.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. | Drug | pralatrexate and vitamin supplementation |
Primary outcome
To Determine the Overall Response Rate (CR+PR)
Time frame: 2 years
by RECIST version 1.1 criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Ho, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pralatrexate With Vitamin B12 and Folic Acid in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine the Overall Response Rate (CR+PR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.