Clinical trial · Interventional

Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors

Phase I Study of the Combination of Sorafenib and Radiation Therapy -/+ Temozolomide for the Treatment of Patients With Brain Metastases and Primary Brain Tumors

NCT00639262CI-TRIAL-00089231completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Sorafenib™ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance radiation response. This study will test the combination of Sorafenib™ and radiation therapy with or without temozolomide to determine tolerance of the combined treatments. Defining safe dosing of Sorafenib™ in this combination therapy will be achieved.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain Metastases	Brain Neoplasm	PROBABILISTIC	0.70
Primary Brain Tumors	Primary Brain Tumor	ONTOLOGY_EXACT	0.98

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Radiotherapy	Radiation	—	UNRESOLVED
Sorafenib	Drug	Sorafenib	ALIAS
Temozolomide	Drug	Temozolomide	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Cohort 1 - Brain Metastasis
description
Sorafenib and Radiotherapy
interventionNames
1. Drug: Sorafenib
2. Radiation: Radiotherapy
type
EXPERIMENTAL
label
Cohort 2 - Gliomas
description
Sorafenib and Radiotherapy, plus Temozolomide
interventionNames
1. Drug: Sorafenib
2. Drug: Temozolomide
3. Radiation: Radiotherapy

Primary outcomes (1)

measure
Maximum Tolerated Dose of Sorafenib
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients requiring a minimum 2-week course of radiation therapy
2. Age \> or = 18
3. All tumors of the central nervous system, or metastasis to the central nervous system.
4. Measurable disease preferred but not required for eligibility
5. Histologically or cytologically documented evidence of malignancy (for infratentorial and supratentorial glioma patients only).
6. Radiographic evidence of brain metastasis
7. ECOG performance status of 0 or 1
8. Life expectancy of \> or = 3 months

Exclusion Criteria:

1. Patients receiving chemotherapy or other investigational drugs must be discontinued 14 days prior to enrollment.
2. Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
4. Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
5. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
6. Active clinically serious infection \> CTCAE Grade 2

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2008
Primary completion: Sep 1, 2012
Completion: Sep 1, 2012
First posted: Mar 20, 2008
Last update posted: May 2, 2025
Enrollment: 35 (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University OTHER
Collaborators: Bayer
Keywords: Sorafenib, Radiation Therapy, Radiotherapy, Temozolomide, Brain Metastases, Brain Tumors

Data updated 22 days agoSource updated May 2, 2025source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.