NCT00616005

Brief Summary

Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

February 3, 2008

Last Update Submit

August 14, 2014

Conditions

Glioblastoma

Keywords

GlioblastomaGBMBrain tumorTemodarTemozolomideIrinotecanCPT-11CamptosarMalignant gliomaAnaplastic astrocytomaGlioblastoma multiforme

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    6 months

Secondary Outcomes (1)

  • Toxicity assessment

    6 months

Study Arms (2)

1

OTHER

Pts taking EIAEDs

Drug: Temodar and Irinotecan

2

OTHER

Pts not taking EIAEDs

Drug: Temodar and Irinotecan

Interventions

Temodar and IrinotecanDRUG

Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle \& every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-days 1, 8, 22, \& 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.

Also known as: Temodar - Temozolomide, Irinotecan - Camptosar - CPT11
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pts have histologically proven supratentorial GBM
  • Pts have newly diagnosed disease
  • There must be measurable disease on contrast-enhanced magnetic resonance imaging performed \<14 days before drug administration. Those who underwent resection must have MRI \<72 hrs/ \>14 days after surgery
  • Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must be treated \<42 days of surgery or biopsy
  • Age \>18 yrs
  • Karnofsky Performance Status \>70 percent
  • Serum creatinine \< 1.5 x ULN
  • Absolute neutrophil count \>1500 cells/microliter; platelet count \>100,000 cells/microliter
  • Serum SGOT \& total bilirubin \<2.5 x ULN
  • Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
  • Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy

You may not qualify if:

  • Pregnant/breast feeding women / women/men w reproductive potential not practicing adequate contraception. This therapy may be associated w potential toxicity to fetus/child that exceeds minimum risks necessary to meet health needs of mother
  • Active infection requiring intravenous antibiotics
  • Known diagnosis of HIV infection
  • Pts w history of another primary malignancy that currently requires active intervention
  • Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition
  • Pts who underwent surgical resection for GBM \<2 weeks of start of treatment
  • Pts who have received prior chemo, biologic therapy, XRT, interstitial brachytherapy/radiosurgery to brain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Links

MeSH Terms

Conditions

GlioblastomaBrain NeoplasmsGliomaAstrocytoma

Interventions

TemozolomideIrinotecan

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloids

Study Officials

  • David A. Reardon, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2008

First Posted

February 14, 2008

Study Start

November 1, 2005

Primary Completion

July 1, 2007

Study Completion

June 1, 2009

Last Updated

August 18, 2014

Record last verified: 2010-08

Locations

US(1)