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CompletedNCT00005951Updated Aug 22, 2014

Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

A Phase 1 interventional study of irinotecan hydrochloride and temozolomide in Brain and Central Nervous System Tumors, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-22.

Sponsored by Duke University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma.
  • Determine the toxicity of this combination therapy in these patients.

OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or none).

Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: Not specified

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

Browse Glioma studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent primary malignant glioma

    • Anaplastic astrocytoma
    • Glioblastoma multiforme
    • Anaplastic oligodendroglioma
    • Gliosarcoma
    • Anaplastic mixed oligoastrocytoma
  • Measurable disease by MRI or CT
  • No immediate radiotherapy required
  • Neurologically stable for at least 2 weeks prior to study

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN

Renal:

  • Blood urea nitrogen and creatinine less than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No other nonmalignant systemic disease
  • No acute infection treated with IV antibiotics
  • No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction)
  • No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 1 prior biologic therapy regimen

Chemotherapy:

  • No more than 1 prior chemotherapy regimen
  • At least 6 weeks since prior chemotherapy, unless evidence of disease progression
  • No prior failure of irinotecan or temozolomide

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 6 weeks since prior radiotherapy, unless evidence of disease progression

Surgery:

  • At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered

Other:

  • No concurrent immunosuppressive agents
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Drugirinotecan hydrochloride
  • Drugtemozolomide
06

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005951
Lead sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Aug 2000
Primary completion
Apr 2006
Completion
Apr 2006
Last update
Aug 22, 2014

Study contacts

Henry S. Friedman, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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