NCT00002971

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery to patients who have malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_1

Geographic Reach
1 country

9 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

June 19, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2003

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2003

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

5.7 years

First QC Date

November 1, 1999

Last Update Submit

June 25, 2018

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

O6-benzylguanineDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Must be undergoing a diagnostic/therapeutic craniotomy for biopsy/resection of recurrent or newly diagnosed (or presumed) cerebral anaplastic astrocytoma or glioblastoma multiforme * Patients undergoing stereotactic biopsy or partial resection are eligible PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 OR * Karnofsky 60-100% Hematopoietic: * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,800/mm3 * Platelet count at least 125,000/mm3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT less than 2 times upper limit of normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 70 mL/min Cardiovascular: * No cardiovascular illnesses that cannot be adequately controlled with * appropriate therapy or would increase risk, e.g.: * Severe cardiac disease such as uncontrolled arrhythmias or conduction * defects * Major problems with edema (e.g., residual leg swelling from deep venous * thrombosis) * Recent coronary artery disease * Poorly controlled hypertension (systolic pressure greater than 180 mm Hg, * diastolic pressure greater than 110 mm Hg) Other: * No other medical illnesses that cannot be adequately controlled with * appropriate therapy or would increase risk, e.g.: * Major problems with edema (e.g., Cushing's syndrome) * Major psychiatric illness * No other malignancy requiring active therapy * Not pregnant or nursing * Fertile patients must us effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Must have failed or received no prior treatment with a nitrosourea, * procarbazine, or temozolomide * No prior O6-benzylguanine * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior radiotherapy * No prior radiotherapy to greater than 10-20% of bone marrow Other: * No concurrent therapy for any other malignancy * At least 2 weeks since other prior investigational drug

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

Sponsors & Collaborators

Study Sites (9)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

O(6)-benzylguanine

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Michael Prados, MD

    UCSF Medical Center at Parnassus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 5, 2003

Study Start

June 19, 1997

Primary Completion

February 20, 2003

Study Completion

January 1, 2009

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

US(9)