Erlotinib and Sirolimus in Treating Patients With Recurrent Malignant Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT00509431
Phase
PHASE1
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

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

Interventions

  • Erlotinib + Sirolimus — DRUG
    In arm I of dose escalation phase,starting dose of erlotinib is 150 mg daily. Starting dose of sirolimus includes a 15 mg loading dose, followed by continuous dosing at 5 mg daily.Dose escalation will proceed according to protocol Phase II of the study was not conducted only Phase I

Study Details

RATIONALE: Erlotinib and sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with sirolimus and to see how well they work in treating patients with recurrent malignant glioma.

Key Dates

First listed
Jul 31, 2007
Start date
Aug 31, 2006
Status verified
Feb 2016
Primary completion
Dec 31, 2011
Completion
Sep 30, 2012

Study Design

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

Arms

  • Experimental: Erlotinib + Sirolimus
    This is an open-label,phase I single-arm dose-escalation and phase II study of continuous, once daily doses of erlotinib administered orally in combination with sirolimus in adult patients with malignant glioma at first, second or third recurrence

Primary Outcome Measure

To determine maximum tolerated dose and dose limiting toxicity of escalating doses of erlotinib in combination with sirolimus [ Time Frame: day 28 of cycle 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center at UCLALos AngelesCalifornia90095-1781-

Find similar trials in Los Angeles, CA

By research site
Jonsson Comprehensive Cancer Center at UCLA· Los Angeles, CA

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