Carcinoma, Squamous CellPhase 1NCT00038584
A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer
A Phase 1 study testing SCH66336 in people with Carcinoma, Squamous Cell and Cancer of Head and Neck, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage tumor cell death. This is a randomized study where patients will receive study drug or no drug. Participants in this study are scheduled to have surgery to remove head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell, Cancer of Head and Neck
- What is being tested?
- SCH66336
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Nov 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically-confirmed stage II, III and IV squamous cell carcinoma of the head and neck.
- Patient's tumor is fully resectable and does not require radiotherapy to the entire buccal mucosa or patients who are to be treated with definitive radiation therapy as long as adequate (>2cm^3) of tissue can be obtained post-therapy with SCH66336.
- ECOG Performance Status of </= 2
- Laboratory values (performed within 14 days prior to administration of SCH 66336):
- White blood cell count greater than 3.0 x 10^9/L
- Platelet count greater than or equal to 150 x 10^9/L
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- Hemoglobin greater than or equal to 10 gm/dL (100 gm/L). Patients may have received transfusions and/or erythropoietin to attain this value. However, they must have been stable without treatment for at least one week in order to be eligible.
- Serum creatinine less than 1.5 times the upper limit of normal.
- Total bilirubin less than 1.5 times the upper limit of normal.
- SGOT or SGPT (only one of these tests needs to be performed) less than or equal to 5.0 times upper limit of normal.
- Able to provide written informed consent.
- Negative pregnancy test (female patients of childbearing potential only), after signing informed consent and prior to registration.
- Patients may have received prior investigational therapy but at least 4 weeks must have elapsed with recovery from all toxicities.
- No more than two prior chemotherapy regimens for systemic disease.
Who cannot join
- Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
- Uncontrolled heart disease (symptomatic ischemic heart disease or congestive heart failure, or either of these conditions with a variable medication requirement).
- Patients with QTc prolongation at baseline.
- Intractable vomiting (e.g., CTC Grade 2 or higher despite antiemetic medication) or any medical condition which could interfere with taking oral medication and gastrointestinal absorption.
- Patient has received prior induction chemotherapy.
- Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent.
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- Prior therapy with a FPT inhibitor.
- Patient's life expectancy is less than 6 months.
- Patient has grade 3 or 4 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
- Patient requires total parenteral nutrition with lipids.
- Chemotherapy, radiation therapy, biologic therapy, or surgery within four weeks prior to administration of SCH 66336. Nitrosourea or mitomycin C administration within 6 weeks of SCH 66336.
- Lack of resolution of all toxic manifestations of prior chemotherapy, biologic or radiation therapy.
- Radiation therapy to greater than 30% of bone marrow as defined in Appendix D. (Whole pelvic radiation alone is not exclusionary.)
- Known HIV positivity or AIDS-related illness.
- Pregnancy or lactation.
- Men or women of childbearing potential who are not using an effective method of contraception. Use of oral contraception or other hormonal modalities by the patient is not permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Head and Neck Squamous Cell Cancer Scheduled for Definitive Therapy
SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage tumor cell death.
This is a randomized study where patients will receive study drug or no drug. Participants in this study are scheduled to have surgery to remove head and neck cancer.
- Conditions
- Carcinoma, Squamous Cell, Cancer of Head and Neck
- Being tested
- SCH66336
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH66336Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2002 (estimated)
- Study startJun 1999
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038584
- Sponsor's protocol ID
- ID98-251
- Status last verified
- Oct 2018
- First submitted
- 31 May 2002
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Head and Neck Squamous Cell Cancer Scheduled for Definitive Therapy
- ClinicalTrials.gov ID
- NCT00038584
- Acronym / sponsor ID
- ID98-251
- Conditions
- Carcinoma, Squamous Cell, Cancer of Head and Neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jun 1999
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 3 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage tumor cell death.
This is a randomized study where patients will receive study drug or no drug. Participants in this study are scheduled to have surgery to remove head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically-confirmed stage II, III and IV squamous cell carcinoma of the head and neck.
- Patient's tumor is fully resectable and does not require radiotherapy to the entire buccal mucosa or patients who are to be treated with definitive radiation therapy as long as adequate (>2cm^3) of tissue can be obtained post-therapy with SCH66336.
- ECOG Performance Status of </= 2
- Laboratory values (performed within 14 days prior to administration of SCH 66336):
- Able to provide written informed consent.
Key exclusion criteria (16 listed)
- Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
- Uncontrolled heart disease (symptomatic ischemic heart disease or congestive heart failure, or either of these conditions with a variable medication requirement).
- Patients with QTc prolongation at baseline.
- Intractable vomiting (e.g., CTC Grade 2 or higher despite antiemetic medication) or any medical condition which could interfere with taking oral medication and gastrointestinal absorption.
- Patient has received prior induction chemotherapy.
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 |
|---|---|---|
| SCH66336 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCH66336 in people with Carcinoma, Squamous Cell and Cancer of Head and Neck, run by M.D. Anderson Cancer Center at 1 site 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 14 inclusion and 16 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 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 30 Oct 2018.