Avelumab With Radiotherapy in Patients With Leptomeningeal Disease (NCT03719768) | Clinical Trial Compass
CompletedPhase 1
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease
United States16 participantsStarted 2019-06-10
Plain-language summary
This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Histologically or cytologically confirmed diagnosis of any cancer except leukemia
* 2\. Patients must have the presence of malignant cells in the CSF (CSF+) OR at least 2 of the 3 following features: 1) clinical signs and symptoms of LMDz 2) characteristic radiographic abnormalities , and 3) "suspicious" CSF (Chamberlain 2017)
* 3\. Patients must have an Eastern Cooperative Oncology Group performance scale of \< 3 OR Karnofsky Performance Status of \>50.
* 4\. An interval of at least 2 weeks after the end of prior radiation therapy to the brain (e.g., stereotactic radiosurgery or other-WBRT is excluded)
* 5\. An interval of at least 4 weeks following any surgical resection of brain lesions prior to treatment
* 6\. Be \> 18 years of age on the day of signing consent
* 7\. Demonstrate adequate organ function as defined in Table 2. All screening labs should be performed with 14 days of treatment initiation
* 8\. Resting baseline O2 saturation by pulse oximetry of \> 92% at rest
* 9\. Patients must have recovered from the toxic effects of prior therapies (\< Grade 1)
* 10\. Provision of signed and dated informed consent form
* 11\. Life expectancy of \> 8 weeks
* 12\. Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential.
* 13\. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last Avelumab treatment administration, if the…
What they're measuring
1
Safety and Dose Limiting Toxicity (DLT) measured by number of subjects with adverse events (AEs)
Timeframe: End of treatment (3 months)
Trial details
NCT IDNCT03719768
SponsorH. Lee Moffitt Cancer Center and Research Institute