Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma (NCT02101905) | Clinical Trial Compass
CompletedPhase 1
Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma
United States29 participantsStarted 2016-11-07
Plain-language summary
This pilot phase I clinical trial studies how well lapatinib ditosylate before surgery works in treating patients with high-grade glioma that has come back after a period of time during which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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:
* Patients must have histologically proven World Health Organization (WHO) grade IV glioblastoma/ gliosarcoma or WHO grade III glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, mixed anaplastic oligoastrocytoma, anaplastic ependymoma) which is progressive or recurrent following radiation therapy +/- chemotherapy
* Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to tolerate MRIs
* Patients may have an unlimited number of prior therapy regimens
* Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:
* 12 weeks from the completion of radiation
* 6 weeks from a nitrosourea chemotherapy
* 3 weeks from a non-nitrosourea chemotherapy
* 4 weeks from any investigational (not Food and Drug Administration \[FDA\]-approved) agents
* 4 weeks from the last treatment with bevacizumab
* 2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)
* Patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:
* Expectation that the surgeon is able to resect at least 500 mg of tumor from enhancing tumor and …
What they're measuring
1
To Determine the Lapatinib Ditosylate Intratumoral Concentration (Pharmacokinetics)
Timeframe: Baseline and day of surgery
2
To Determine the Ratio of Phosphorylated (p)EGFR/Total EGFR (PD) in Tumor Tissue