NCT00004113

Brief 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 malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1999

Geographic Reach
1 country

1 active site

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

June 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

December 10, 1999

Last Update Submit

June 18, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed recurrent malignant glioma, including: Glioblastoma Gliosarcoma High grade glioma Anaplastic astrocytoma Anaplastic mixed oligoastrocytoma Anaplastic oligodendroglioma Must have evidence of tumor recurrence or progression on gadolinium enhanced MRI or CT scan following radiotherapy with or without chemotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 3 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: No nonmalignant systemic disease that would cause patient to be a poor medical risk No acute infection requiring intravenous antibiotics No psychological disorder that would interfere with study compliance HIV negative No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No prior or concurrent malignancy, except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior temozolomide or dacarbazine Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior external beam radiotherapy At least 8 weeks since prior stereotactic radiosurgery Surgery: At least 2 weeks since prior brain biopsy, craniotomy, or other surgery

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Khan RB, Raizer JJ, Malkin MG, Bazylewicz KA, Abrey LE. A phase II study of extended low-dose temozolomide in recurrent malignant gliomas. Neuro Oncol. 2002 Jan;4(1):39-43. doi: 10.1093/neuonc/4.1.39.

    PMID: 11772431RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGliomaGliosarcoma

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 Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lauren E. Abrey, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 21, 2004

Study Start

June 1, 1999

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)