CClinicalTrials.gg
Status unknownNCT00004204Updated Jan 6, 2014

Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

A Phase 2 interventional study of temozolomide in Brain and Central Nervous System Tumors, sponsored by Herbert Irving Comprehensive Cancer Center. Status unknown at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-06.

Sponsored by Herbert Irving Comprehensive Cancer Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
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.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
  • Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
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

Herbert Irving Comprehensive Cancer Center is the lead sponsor of 32 studies on the registry; none are open to participants now.

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 proven recurrent or progressive malignant glioma of one of the following types:

    • Anaplastic oligodendroglioma or oligoastrocytoma
    • Anaplastic astrocytoma
    • Glioblastoma multiforme (stratum closed to accrual 11/30/01)
  • Patients who have failed radiotherapy are eligible
  • Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

  • SGOT or SGPT less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)

Renal:

  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other serious concurrent infection or other medical illness that would preclude study entry
  • No frequent vomiting or partial bowel obstruction
  • HIV negative
  • No AIDS-related illness
  • No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent epoetin alfa

Chemotherapy:

  • At least 6 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)

Surgery:

  • Recovered from prior surgery

Other:

  • No other concurrent investigational agents
  • Concurrent anticonvulsant therapy allowed
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugtemozolomide
06

Study locations

10 sites
  • Stanford University Medical Center
    Stanford, California 94305-5408, United States
  • Mount Sinai Comprehensive Cancer Center
    Miami Beach, Florida 33140, United States
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Cancer Center of Albany Medical Center
    Albany, New York 12208, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • Nalitt Institute for Cancer And Blood Related Diseases
    Staten Island, New York 10305, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • Neurological Clinic
    Portland, Oregon 97210, United States
  • University of Pennsylvania Cancer Center
    Philadelphia, Pennsylvania 19104-4283, United States
  • Froedtert Memorial Lutheran Hospital
    Milwaukee, Wisconsin 53226, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004204
Lead sponsor
Herbert Irving Comprehensive Cancer Center
First posted
Jul 18, 2003
Start date
Feb 2000
Last update
Jan 6, 2014

Study contacts

Casilda Balmaceda, MD
study chair · Herbert Irving Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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