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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02101905
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lapatinib — DRUG
    Given PO
  • Lapatinib Ditosylate — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgical resection of tumor

Study Details

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.

Key Dates

Start date
Nov 7, 2016
Status verified
Nov 2024
Primary completion
Oct 19, 2021
Completion
Oct 30, 2024

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (lapatinib ditosylate, surgery)
    Patients receive lapatinib ditosylate PO BID on days -2 to 0. Within 3-5 hours after last dose of lapatinib ditosylate, patients undergo surgical resection of tumor on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Reference Group (surgery, lapatinib ditosylate)
    Patients undergo surgery on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

To Determine the Lapatinib Ditosylate Intratumoral Concentration (Pharmacokinetics) [ Time Frame: Baseline and day of surgery ]

Locations (12)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MIMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJ

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