NCT00362817

Brief Summary

Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2004

Typical duration 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

Study Start

First participant enrolled

October 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

May 6, 2015

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

August 8, 2006

Results QC Date

February 26, 2015

Last Update Submit

May 1, 2017

Conditions

Brain TumorBrain Metastases

Keywords

RecurrentSymptomatic

Outcome Measures

Primary Outcomes (1)

  • Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide

    Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a \>50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a \>25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.

    up to 1 year

Secondary Outcomes (5)

  • Analyze Patients Time to Progression

    up to 60 weeks

  • Determine the Overall Survival of Patients

    up to 64 weeks

  • Determine the Cause of Death of Patients After Treatment

    up to 1 year

  • The Incidence and Severity of Centeral Nervous System (CNS) Toxicities

    up to 24 weeks

  • Quality of Life Assessment

    up to 2 years

Study Arms (1)

Temozolomide & Intra-Arterial (IA) carboplatin

EXPERIMENTAL

Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin

Drug: carboplatinDrug: temozolomide

Interventions

carboplatinDRUG

IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.

Also known as: Paraplatin, CBDCA
Temozolomide & Intra-Arterial (IA) carboplatin
temozolomideDRUG

150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.

Also known as: Temodar
Temozolomide & Intra-Arterial (IA) carboplatin

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed systemic cancer

You may not qualify if:

  • Pregnant
  • Known CNS meningeal involvement with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsRecurrence

Interventions

CarboplatinTemozolomide

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Herbert Newton,
Organization
The Ohio State University Medical Center and James Cancer Hospital & Solove Research Inst.
newton.12@osu.edu
614-293-4448

Study Officials

  • Herbert Newton, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

October 1, 2004

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

June 1, 2017

Results First Posted

May 6, 2015

Record last verified: 2017-05

Locations

US(1)