Status:
TERMINATED
Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Schering-Plough
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest d...
Detailed Description
At the start of the study, patients will be informed which dose level they will be treated with. On day 1, patients will have a physical exam and several blood draws including draws to measure the lev...
Eligibility Criteria
Inclusion
- Patients must have cytologically/histologically documented solid tumor malignancies
- Age \> 18 years old
- Patients must be candidates to receive WBR for unresectable brain metastases
- Patients must have ECOG performance status 0-2
- Patients must be able to give informed consent and able to follow guidelines given in the study
- Neurologic Function Status 0,1, or 2
- The patient has no major impairment of hematological function, as defined by the following laboratory parameters: WBC \>3.0x10\^9/L; ANC \> 1.5 x 10\^9/L; Hgb \>9.0g/dL; PLT \>100x10\^9/L. Red blood cell transfusions and repeat evaluations for study entry are allowed
- Patients must have adequate renal and normal hepatic function (creatinine \< 1.5 x upper limit of normal (ULN), bilirubin and SGOT (AST), SGPT (ALT) within 1.5 x the upper institutional normal limits) obtained within 4 weeks prior to registration.
- All patients of reproductive potential must use an effective method of contraception during the study and six months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year).
- Women of childbearing age must have a negative pregnancy test
- Patients must have 10 mm or greater brain lesion on MRI scan performed within 4 weeks of enrollment
Exclusion
- Prior whole brain radiation
- More than 1 active malignancy which may potentially cause brain metastasis
- Patients on phenytoin, carbamazepine, phenobarbital, felbamate, meropenem, rifampin (Levetiracetam will be permitted)
- Patients with active or any history of seizure disorders
- Patients with uncontrolled nausea and vomiting
- Chemotherapy, radiotherapy, or hormonal therapy within 2 weeks prior to entering the study or have not recovered from prior treatment-related toxicities (grade 2 or less)
- Patients receiving any other investigational agents
- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
- Leptomeningeal disease or hydrocephalous on MRI scan performed within 4 weeks of enrollment
- Pregnant and breast feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00437957
Start Date
December 1 2006
End Date
April 1 2009
Last Update
February 23 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612