Ph I SU011248 + Irinotecan in Treatment of Pts w MG

NCT00611728 | Completed Phase 1

• 1 other identifier: Pro00000931
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Glioblastoma

Keywords

Glioblastoma; CPT 11; Sutent; Sunitinib; Sunitinib malate; Malignant Glioma; GBM; Irinotecan; Camptosar; Anaplastic astrocytoma; Anaplastic oligodendroglioma; Anaplastic oligoastrocytoma; SU011248; Brain tumor; Recurrent malignant glioma

Outcome Measures

Primary Outcomes (1)

• Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs

  6 months

Secondary Outcomes (4)

• Demographic & baseline characteristics

  6 months

• Efficacy observations & measurements

  6 months

• Safety observations & measurements

  6 months

• PK measurements

  6 months

Interventions

SU011248 & Irinotecan DRUG

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.

Also known as: SU011248-Sutent-Sunitinib, Irinotecan-CPT 11-Camptosar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pts confirmed GBM, GS, AA, AO \& AOA w recurrent disease following standard therapy consisting of at least external beam XRT \& temo chemo
• Pts not had tumor biopsy \<1 week/surgical resection \<2 weeks prior to starting study drug
• Pts should be on non-increasing dose of steroids \>7 days prior to obtaining baseline Gd-MRI of brain
• Age \>18yrs
• KPS \>70
• ANC \>1.5 x 10 9/L
• Hgb \>9 g/dL
• Platelets \>100 x 10 9/L
• AST/SGOT \& ALT/SGPT \<2.5 x ULN
• Serum bilirubin \<1.5 x ULN
• Serum CA \<12 mg/dL
• Serum creatinine \<1.5 x ULN/measured 24-hr CrCl\>50mL/min/1.73m\^2
• Pt has ability to understand \& provide signed informed consent that fulfills IRB guidelines

You may not qualify if:

• Prior gr3/\>toxicity/failure to CPT-11 therapy
• Prior Sunitinib malate therapy
• Concurrent administration of EIAEDs
• Major surgery \<2 weeks of enrollment
• History of impaired cardiac function
• Other clinically significant cardiac diseases
• Uncontrolled diabetes
• Active/uncontrolled infection requiring intravenous antibiotics
• Impairment of GI function/GI disease that may significantly alter absorption of Sunitinib malate Sutent
• Acute/chronic liver/renal disease
• Cerebrovascular accident/transient ischemic attack \<6mths of study enrollment
• Pulmonary embolism \<6mths of study enrollment
• Pre-existing thyroid abnormality w thyroid function that can not be maintained in normal range w medication
• Pts taking warfarin sodium
• Pts have received chemo ≤4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center at DUKE

MeSH Terms

Conditions

Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma; Brain Neoplasms

Interventions

Sunitinib; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids

Study Officials

• David A. Reardon, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 21, 2014

Record last verified: 2011-12

Locations

US (1)