Study of Irinotecan and Bortezomib in Children With Recurrent/Refractory Neuroblastoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT00644696
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan and Bortezomib — DRUG
    Dose level-1a: IV Irinotecan 30 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-1: IV Irinotecan 35 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-2: IV Irinotecan 40 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-3: IV Irinotecan 45 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-4: IV Irinotecan 50 mg/m2/day, IV bortezomib 1.2mg/m2/day

Study Details

This Phase One pediatric trial seeks to take advantage of the susceptibility of neuroblastoma to proteasome inhibitors, proven in vitro, along with the proven in vitro synergy of bortezomib with irinotecan and the successful Phase One pediatric trials of bortezomib to create a treatment using these two drugs in combination to treat refractory/recurrent neuroblastoma in children and young adults 25 and under.

Key Dates

Start date
Apr 30, 2008
Status verified
Jul 2017
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

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

Arms

  • Experimental: Irinotecan and Bortezomib
    Irinotecan and Bortezomib will both be administered

Primary Outcome Measure

Determine highest dose of IV irinotecan administered in conjunction with bortezomib without causing severe side effects. [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
The University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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