NCT00005951

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_1

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

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

August 22, 2014

Status Verified

February 1, 2013

Enrollment Period

5.7 years

First QC Date

July 5, 2000

Last Update Submit

August 20, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

irinotecan hydrochlorideDRUG
temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent primary malignant glioma * Anaplastic astrocytoma * Glioblastoma multiforme * Anaplastic oligodendroglioma * Gliosarcoma * Anaplastic mixed oligoastrocytoma * Measurable disease by MRI or CT * No immediate radiotherapy required * Neurologically stable for at least 2 weeks prior to study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater 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: * Blood urea nitrogen and creatinine less than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other nonmalignant systemic disease * No acute infection treated with IV antibiotics * No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction) * No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic therapy regimen Chemotherapy: * No more than 1 prior chemotherapy regimen * At least 6 weeks since prior chemotherapy, unless evidence of disease progression * No prior failure of irinotecan or temozolomide Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 6 weeks since prior radiotherapy, unless evidence of disease progression Surgery: * At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: * No concurrent immunosuppressive agents

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGliomaGliosarcoma

Interventions

IrinotecanTemozolomide

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)

CamptothecinAlkaloidsHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Henry S. Friedman, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

August 22, 2014

Record last verified: 2013-02

Locations

US(1)