Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Metastases Central Nervous System (CNS) Metastases

Keywords

TemozolomideTopotecanCentral Nervous System MetastasesChemotherapyBrain MetastasesSolid Tumors

Outcome Measures

Primary Outcomes (1)

Radiologic Response
The primary objective of this study is to determine the overall rate of radiologic response of brain metastases to combination chemotherapy with temozolomide and topotecan in patients with CNS metastases of solid tumors
5 years

Secondary Outcomes (1)

Median Overall Survival
5 years

Study Arms (1)

Temozolomide/Topotecan

EXPERIMENTAL

Temozolomide pills are to be taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule. Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.

Drug: TopotecanDrug: Temozolomide

Interventions

TopotecanDrug

Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.

Also known as: Hycamtin

Temozolomide/Topotecan

TemozolomideDrug

Temozolomide is taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule.

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

To be eligible for the study, patients must have evidence of progressive CNS metastases of a solid tumor (new or progressing lesions), and either:
Have failed prior WBRT.

Sponsors & Collaborators

The Methodist Hospital Research Institute
Otherlead

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Methodist Neurological Institute - Department of Neurosurgery

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

TopotecanTemozolomide

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

Pamela Z New, M.D.
Methodist Neurological Institute
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

November 19, 2012

First Posted

November 29, 2012

Study Start

March 2007

Actual (reported)

Primary Completion

Study Stopped

Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Temozolomide/Topotecan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Temozolomide/Topotecan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations