NCT00003466

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

July 9, 2014

Status Verified

February 1, 2013

Enrollment Period

7.3 years

First QC Date

November 1, 1999

Last Update Submit

July 7, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult mixed gliomachildhood mixed gliomaadult pilocytic astrocytomaadult subependymomarecurrent childhood cerebral astrocytomaadult brain stem gliomarecurrent childhood brain stem gliomauntreated childhood brain stem gliomarecurrent childhood visual pathway and hypothalamic gliomauntreated childhood visual pathway and hypothalamic gliomaadult oligodendrogliomaadult diffuse astrocytoma

Outcome Measures

Primary Outcomes (2)

  • Response rate

  • Activity of temozolomide

Interventions

temozolomideDRUG

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: * Astrocytoma * Oligodendroglioma * Mixed glioma * Optic pathway glioma\* * Pontine glioma\* NOTE: \*Biopsy not required * Patients with optic pathway glioma must also meet the following criteria: * Progressive loss of vision as defined by doubling of octaves * Visual acuity loss not explained by other causes * Increase in proptosis of greater than 3 mm * Increase in diameter of optic nerve of at least 2 mm on neuroimaging * Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 4 and over Performance status: * Karnofsky 70-100% Life expectancy: * More 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: * Creatinine less than 1.5 times ULN * BUN less than 1.5 times ULN Other: * Must be neurologically stable * No systemic disease * No acute infection requiring IV antibiotics * No frequent vomiting * No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) * No other prior or concurrent malignancies except: * Surgically cured carcinoma in situ of the cervix * Basal or squamous cell skin cancer * HIV negative * No AIDS-related illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: * At least 6 weeks since prior chemotherapy unless evidence of disease progression * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior radiotherapy unless evidence of disease progression * No concurrent radiotherapy Surgery: * At least 3 weeks since prior surgery unless evidence of disease progression * Recovered from all prior surgery Other: * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGliomaAstrocytomaGlioma, SubependymalOptic Nerve GliomaOligodendroglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEpendymomaOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henry S. Friedman, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1998

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

July 9, 2014

Record last verified: 2013-02

Locations

US(2)