Clareo Health | Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)
Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
With
Quintiles, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
Brain metastases \>=1 cm presenting or in progression following \>=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
Age \<=70 years.
Performance status 0-2 (ECOG-WHO scale).
Blood leukocytes \>=3.5 x 10\^9/L and platelets \>=100 x 10\^9/L.
Bilirubin \<=25 M/L.
Seric transaminases \<=2 x upper limit of normal values.
Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
Previous whole brain irradiation.
Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
