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Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma

NCT02101905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

  • Anaplastic Astrocytoma
  • Anaplastic Ependymoma
  • Anaplastic Oligodendroglioma
  • Gliosarcoma
  • Mixed Glioma
  • Recurrent Adult Brain Neoplasm
  • Recurrent Glioblastoma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lapatinib

Given PO

DRUG

Lapatinib Ditosylate

Given PO

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection of tumor

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Timothy F Cloughesy · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-07
Primary Completion
2021-10-19
Completion
2024-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101905 on ClinicalTrials.gov