Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT00826241
Phase
PHASE2
Status
Completed

Conditions

  • Brain Tumors
  • Spinal Cord Tumors

Eligibility Criteria

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

Interventions

  • Temozolomide — DRUG
    Starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle.
  • Lapatinib — DRUG
    Starting dose 1250 mg daily by mouth.

Study Details

The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.

Key Dates

Start date
Jan 31, 2009
Status verified
Mar 2019
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018

Study Design

Enrollment
58 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolomide + Lapatinib
    Temozolomide starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.

Primary Outcome Measure

Time to Progression [ Time Frame: Assessed every two months till disease progression, up to 4 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin School of Medicine and Public HealthMadisonWisconsin53792-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Pittsburgh Medical Center - Hillman Cancer Center· Pittsburgh, PAUniversity of Texas MD Anderson Cancer Center· Houston, TXUniversity of Wisconsin School of Medicine and Public Health· Madison, WI

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