Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087061
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: gimatecan Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
  • Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)


  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the pharmacokinetic behaviors of this drug in these patients.
  • Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
  • Determine the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no).

  • Phase I: Patients receive oral gimatecan once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

  • Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed for at least 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I [15-21 per stratum] and 21-41 for phase II) will be accrued for this study within 24 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial
Study Start Date : May 2004
Actual Study Completion Date : June 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)

    • Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI
  • Tumor progression after prior surgery, radiotherapy, or chemotherapy
  • Measurable or evaluable disease
  • Failed prior standard curative or palliative therapy (phase I only)



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • Bilirubin normal


  • Creatinine ≤ 1.5 times ULN


  • No myocardial infarction with the past year
  • No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)
  • No irreversible arrhythmias requiring permanent medication
  • No uncontrolled hypertension


  • No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:

    • Active peptic ulcer
    • Inflammatory bowel disease
    • Known intolerance to lactose
    • Malabsorption syndromes
    • Intestinal sub-occlusion


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No active infection
  • No mentally incapacitated patients
  • No other concurrent severe disease that would preclude study participation


Biologic therapy

  • No concurrent immunotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No more than 1 prior chemotherapy regimen
  • No other concurrent chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed if dose stable for the past 2 weeks
  • No concurrent hormonal therapy


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior surgical resection
  • No prior gastrointestinal surgery that would affect drug absorption


  • More than 4 weeks since prior participation in any other investigational drug study
  • More than 72 hours since prior systemic antibiotics
  • No concurrent H2 antagonists, antacids, or proton pump inhibitors

    • If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
  • No other concurrent immunosuppressive agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087061

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Timothy F. Cloughesy, MD Jonsson Comprehensive Cancer Center Identifier: NCT00087061     History of Changes
Other Study ID Numbers: SIGMATAU-ST-01-402
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
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