Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Johns Hopkins All Children's Hospital
Study ID
NCT00876993
Phase
PHASE1
Status
Completed

Conditions

  • Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
18 Months - 23 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg IV on day 1 and day 15 of a 28 day cycle
  • Irinotecan — DRUG
    Irinotecan 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the Maximum Tolerated Dose of temozolomide is not reached at dose level 3, then dose level 4 will be an escalation of irinotecan to 150mg/m2.
  • Temozolomide — DRUG
    For the first cohort (dose level 0) of patients, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO for the first course. Doses will be escalated according to standard phase I dose escalation criteria. Dose levels are as follows (Dose level 1 = 125mg/m2, Dose level 2 = 175mg/m2, Dose levels 3 and 4 = 200 mg/m2)

Study Details

Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.

Key Dates

Start date
Sep 30, 2008
Status verified
Jun 2023
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0
    Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 75 mg/m\^2 PO
  • Experimental: Dose Level 1
    Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 125 mg/m\^2 PO
  • Experimental: Dose Level 2
    Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 175 mg/m\^2 PO
  • Experimental: Dose Level 3
    Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 200 mg/m\^2 PO
  • Experimental: Dose Level 4
    Bevacizmuab 10 mg/kg IV Irinotecan 150 mg/m\^2 IV Temozolomide 200 mg/m\^2 PO

Primary Outcome Measure

Measurement of Number of Adverse Events [ Time Frame: Two 28-day cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-

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