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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00639262
First received: March 13, 2008
Last updated: March 27, 2014
Last verified: March 2014

March 13, 2008
March 27, 2014
March 2008
June 2011   (final data collection date for primary outcome measure)
Maximum Tolerated Dose of Sorafenib [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]
To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Sorafenib and radiotherapy -/+ temozolomide patients with malignancies of the brain.
maximum tolerated dose of sorafenib [ Time Frame: 30 days post treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00639262 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]
    Response rate (in those patients with measurable disease)
  • Prediction of 1-year Recurrence [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
    Determine if an increase in urinary VEGF and MMP levels, from the end of treatment to a patient's 1-month follow-up examination, is predictive of 1-year recurrence
  • Safety and Toxicity of Sorafenib [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]
    To evaluate the safety and toxicity profile of Sorafenib in combination with radiation therapy -/+ temozolomide
Not Provided
Not Provided
Not Provided
 
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

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.

The current standard of care for patients with brain metastatic malignancies is to receive radiation therapy alone, while the standard of care for patients with high grade primary brain malignancies, astrocytomas, is to receive to receive concurrent temozolomide with radiation therapy. In this phase I study, based on the range of efficacy of kinase inhibitors and its ability to cross the blood-brain barrier we will conduct two parallel studies. The first is to combine sorafenib and radiation therapy for the treatment of patients with brain metastases and the second is to combine sorafenib with temozolomide for primary brain tumors.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Metastases
  • Primary Brain Tumors
  • Drug: Sorafenib
    Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)
    Other Name: Nexavar
  • Drug: Temozolomide
    For Cohort 2 - Gliomas only.
    Other Names:
    • Temodar
    • Temodal
  • Radiation: Radiotherapy
    Radiation Therapy (XRT)
    Other Names:
    • XRT
    • Radiation therapy
    • radiation oncology
  • Experimental: Cohort 1 - Brain Metastasis
    Sorafenib and Radiotherapy
    Interventions:
    • Drug: Sorafenib
    • Radiation: Radiotherapy
  • Experimental: Cohort 2 - Gliomas
    Sorafenib and Radiotherapy, plus Temozolomide
    Interventions:
    • Drug: Sorafenib
    • Drug: Temozolomide
    • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
March 2015
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639262
07P.381, 2006-58
Yes
Thomas Jefferson University
Thomas Jefferson University
Bayer
Principal Investigator: Adam Dicker, MD, PhD Thomas Jefferson University
Thomas Jefferson University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP