Testing Lenvatinib in Patients with Adenoid Cystic Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02780310
This clinical trial is exploring the effects of the drug lenvatinib on adenoid cystic carcinoma, a type of cancer. The study aims to see if lenvatinib can shrink the cancer by at least 25%.
Patient Parameters
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Program Overview
The purpose of this study is to find out how the drug lenvatinib affects patients with adenoid cystic carcinoma, a type of cancer. Researchers want to see if lenvatinib can shrink the cancer by at least one-quarter of its current size. Lenvatinib is a pill that may slow down cancer cell growth and reduce the blood supply to tumors. This study will help determine if lenvatinib is a useful treatment for people with adenoid cystic carcinoma.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of adenoid cystic carcinoma, including cancers from non-salivary gland sites.
- Cancer must have returned or spread and cannot be treated with surgery or radiotherapy.
- At least 2 weeks must have passed since the last cancer treatment, with recovery from any side effects.
- Must have measurable cancer that can be tracked by scans.
- Must have a new or worsening cancer lesion or symptoms within 6 months before joining the study.
- Must provide a sample of the tumor tissue for study purposes.
- Must be 18 years or older.
- Must be in good general health with a performance status score of less than 2.
- Must have adequate blood, liver, and kidney function based on specific tests.
- Must be able to understand and sign a consent form.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
- Must agree to use effective birth control during the study and for 3 months after the last dose.
- Must be able to swallow pills.
Exclusion Criteria
- Cannot be receiving other cancer treatments besides the study drug.
- Cannot have used lenvatinib before.
- Cannot have uncontrolled high blood pressure.
- Cannot be using another experimental drug or device.
- Cannot have significant protein in the urine.
- Cannot have serious heart problems or recent heart attacks.
- Cannot have had recent blood clots or strokes.
- Cannot have untreated or symptomatic brain tumors.
- Cannot have had major surgery or injury recently.
- Cannot have bleeding disorders or recent severe bleeding.
- Cannot be on unstable blood thinners.
- Cannot have active infections like HIV or hepatitis.
- Cannot have a non-healing wound or ulcer.
- Cannot have kidney failure requiring dialysis.
- Cannot have a seizure disorder needing medication.
- Cannot have lung disease with symptoms.
- Cannot have had an organ transplant.
- Cannot have conditions affecting absorption of medication.
- Cannot be pregnant or breastfeeding.
- Cannot have any condition that makes participation unsafe.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Cancer Center @ Suffolk | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York |
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