NCT00034697

Brief Summary

Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2001

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

June 28, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2003

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 1, 2002

Last Update Submit

May 22, 2017

Conditions

Metastases, NeoplasmCarcinoma, Non-Small-Cell LungBrain Neoplasms

Keywords

Brain metsnon-small cell lung cancer

Interventions

temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic confirmation of non-small-cell lung cancer
  • Stable systemic disease
  • Maximum of one prior chemotherapy regimen for metastatic systemic disease
  • Radiotherapy for local control or palliative bony lesions is allowed
  • Karnofsky of greater than or equal to 70%
  • Adequate hematologic, renal and liver function

You may not qualify if:

  • Patients eligible for surgery of the brain
  • Any previous chemotherapy for the brain metastasis
  • Chemotherapy within 4 weeks or previous temozolomide
  • Prior radiotherapy to the brain
  • Radiation therapy to greater than 50% of the bone marrow
  • Insufficient recovery from previous therapies
  • Active nonmalignant systemic disease
  • Inability to take oral medication
  • Pregnant or nursing women
  • Non use of adequate contraceptive techniques, negative urine pregnancy test is required
  • Known AIDS related illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasm MetastasisCarcinoma, Non-Small-Cell LungBrain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2002

First Posted

May 2, 2002

Study Start

June 28, 2001

Primary Completion

January 30, 2003

Study Completion

January 30, 2003

Last Updated

May 23, 2017

Record last verified: 2017-05