Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT02022644
Phase
PHASE1
Status
Completed

Conditions

  • High Grade Glioma

Eligibility Criteria

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

Interventions

  • nanoliposomal irinotecan — DRUG
    The drug named here (nanoliposomal irinotecan) will be used in varying amounts, based on tumor volume.

Study Details

This is a single center, dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery (CED).

Key Dates

Start date
Oct 23, 2014
Status verified
Jun 2023
Primary completion
Dec 31, 2020
Completion
May 31, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - 20 mg
    Tumor diameter: 1 cm, Tumor volume: \~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 20 mg/ml, Infusion time: 6-24 hours, no more than 48
  • Experimental: Group 2 - 40 mg
    Tumor diameter: 2 cm,Tumor volume: \~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 3 - 140 mg
    Tumor diameter: 3 cm, Tumor volume: \~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 140 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 4 - 340 mg
    Tumor diameter: 4 cm, Tumor volume: \~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 340 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 5 - 40 mg
    Tumor diameter: 1 cm, Tumor volume: \~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 6 - 80 mg
    Tumor diameter: 2 cm, Tumor volume: \~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 80 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 7 - 280 mg
    Tumor diameter: 3 cm, Tumor volume: \~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 280 mg/ml, Infusion Time: 6-24 hours, no more than 48
  • Experimental: Group 8 - 680 mg
    Tumor diameter: 4 cm, Tumor volume: \~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 680 mg/ml, Infusion Time: 6-24 hours, no more than 48

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 30 days post-infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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