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Ph I SU011248 + Irinotecan in Treatment of Pts w MG

NCT00611728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-07-21

No results posted yet for this study

Summary

Primary Objectives To determine maxi tolerated dose \& dose limiting toxicity of SU011248 + Irinotecan in recurrent MG pts not on EIAEDs To characterize safety \& tolerability of SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate pharmacokinetic profile of SU011248 \& Irinotecan when co-administered in pts w MG To evaluate anti-tumor activity of SU011248 + Irinotecan

Conditions

Interventions

DRUG

SU011248 & Irinotecan

Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 \& 1/2 hrs on 1st day of each cycle \& then again on days 14 \& 28. Sutent is approved for adult subjects w some forms of kidney cancer. It is considered "investigational" for brain tumors. Dosing will begin on day 1 of cycle 1 \& continue daily for 4 wks by mouth. Irinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered "investigational" for brain tumors. Irinotecan dose will depend on your height \& weight. Irinotecan will be given intravenously over 90 min on days 1, 14 \& 28 of 6wk cycle. You will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, \& then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, \& then within 1 week prior to completion of every other cycle.

Sponsors & Collaborators

Principal Investigators

  • David A. Reardon, MD · Duke Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611728 on ClinicalTrials.gov