NCT00005812

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

4.3 years

First QC Date

June 2, 2000

Last Update Submit

May 13, 2013

Conditions

Brain TumorsCentral Nervous System TumorsLeptomeningeal Metastases

Keywords

leptomeningeal metastasestemozolomide

Outcome Measures

Primary Outcomes (1)

  • Objective Response

    Response will be assessed clinically, cytologically, and radiographically.

    Every 6 weeks

Secondary Outcomes (3)

  • Pharmacokinetics

    Every 6 weeks

  • Survival

    every 6 weeks

  • Quality of Life

    Baseline, weekly during cycle 1, before each additional cycle

Study Arms (1)

Temozolomide

EXPERIMENTAL

Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until: * disease progression * intolerable toxicity * complete response - 2 full additional cycles * if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.

Drug: temozolomide

Interventions

temozolomideDRUG
Temozolomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Documented leptomeningeal metastases * Carcinomatous meningitis that is previously untreated or failed prior therapy OR * Lymphomatous meningitis * Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious * Age 18 and over * Karnofsky Performance Status 60-100% * Life expectancy of at least 6 weeks * Absolute neutrophil count greater than 1,500/μL * Platelet count greater than 100,000/μL * Creatinine no greater than 2.0 mg/dL * No congestive heart failure * No unstable angina * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir * No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting) * No uncontrolled infection * Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed * No other concurrent chemotherapy for other sites of disease * No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas * No prior radiotherapy to greater than 30% of bone marrow * Prior radiotherapy to the neuroaxis allowed * No concurrent radiotherapy for other sites of disease or for progressive disease * Recovered from any prior recent therapy

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

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (1)

  • Davis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021

    RESULT

MeSH Terms

Conditions

Brain NeoplasmsCentral Nervous System NeoplasmsMeningeal Carcinomatosis

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas H. Davis, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

January 1, 2000

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

US(1)