Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade I… (NCT03927274) | Clinical Trial Compass
TerminatedEarly Phase 1
Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
Stopped: Funding unavailable
United States3 participantsStarted 2019-06-20
Plain-language summary
The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression.
* 18 years of age or older
* Karnofsky Performance Status 70-100;
* MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
* Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
* Adequate organ function as indicated in protocol
Exclusion Criteria:
* Participant is mentally or legally incapacitated at the time of the study;
* Known HIV(+) or has been diagnosed with AIDS
* Participation in another investigational drug study in the prior 4 weeks
* Positive pregnancy test in a female
* Patient, in the opinion of the investigator, is likely to be poorly compliant.
* Diffuse subependymal or Cerebral Spinal Fluid (CSF) disease
* Tumors involving the cerebellum
* Tumor enhancement involving both hemispheres
* Active infection requiring treatment
* Unexplained febrile illness
* Radiation or chemotherapy within 4 weeks of enrollment
* Systemic diseases associated with unacceptable anesthesia or operative risk
* Inability to undergo …
What they're measuring
1
Distribution of topotecan in tumor tissue
Timeframe: Treatment day 1
Trial details
NCT IDNCT03927274
SponsorH. Lee Moffitt Cancer Center and Research Institute