NCT00064363

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

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, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

July 8, 2003

Last Update Submit

March 7, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult anaplastic astrocytomaadult glioblastomaadult anaplastic oligodendrogliomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcomaadult brain stem glioma

Outcome Measures

Primary Outcomes (1)

  • Progression at 6 months

Interventions

talampanelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed high-grade glioma, including any of the following: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Patients with clinical and radiographic diagnosis of brain stem glioma are also eligible * Evidence of tumor progression by MRI or CT scan * Scan must be performed while patient is on a stable steroid dose for at least 5 days * Must have failed prior radiotherapy * Residual disease after prior resection of recurrent or progressive tumor is allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN * No significant active hepatic disease Renal * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease Cardiac * No significant active cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception during and for 2 months after study participation * Able to swallow whole capsules * No active infection requiring IV antibiotics * No significant active psychiatric disease that would preclude use of the study drug * No other significant uncontrolled medical illness that would preclude study participation * No other active life-threatening malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * At least 1 week since prior interferon or thalidomide * No concurrent anticancer immunotherapy Chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 6 weeks since prior nitrosoureas * No other concurrent anticancer chemotherapy Endocrine therapy * See Disease Characteristics * At least 1 week since prior tamoxifen * Concurrent steroids for the control of increased intracranial pressure allowed Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent anticancer radiotherapy Surgery * See Disease Characteristics * Prior recent resection of recurrent or progressive disease allowed Other * Recovered from all prior therapy * At least 1 week since prior noncytotoxic agents (e.g., isotretinoin), except for radiosensitizers * At least 4 weeks since prior investigational agents * At least 4 weeks since prior cytotoxic therapy * No other concurrent investigational 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)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Iwamoto FM, Kreisl TN, Kim L, Duic JP, Butman JA, Albert PS, Fine HA. Phase 2 trial of talampanel, a glutamate receptor inhibitor, for adults with recurrent malignant gliomas. Cancer. 2010 Apr 1;116(7):1776-82. doi: 10.1002/cncr.24957.

    PMID: 20143438RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsAstrocytomaGlioblastomaOligodendrogliomaGliomaGliosarcoma

Interventions

talampanel

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

Study Officials

  • Howard A. Fine, MD

    NCI - Neuro-Oncology Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

June 1, 2003

Study Completion

February 1, 2007

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)