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Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 5, 2000
Last updated: August 20, 2014
Last verified: February 2013

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.

Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: irinotecan hydrochloride
Drug: temozolomide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)

Resource links provided by NLM:

Further study details as provided by Duke University:

Study Start Date: August 2000
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.



Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 12 weeks


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


  • 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


  • Blood urea nitrogen and creatinine less than 1.5 times ULN


  • 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


Biologic therapy:

  • No more than 1 prior biologic therapy regimen


  • 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


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


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


  • No concurrent immunosuppressive agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005951

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
  More Information

Responsible Party: Duke University Identifier: NCT00005951     History of Changes
Other Study ID Numbers: 1087  DUMC-1087-02-6R3  DUMC-001087-006R1  DUMC-1067-99-6  NCI-G00-1795  DUMC-001087-01-6R2  CDR0000067931 
Study First Received: July 5, 2000
Last Updated: August 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents processed this record on October 20, 2016