Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Metastases of Central Nervous System
Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolle...
Eligibility Criteria
Inclusion
- 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.
- Creatinine \<=150 M/L, creatinine clearance \>=60 mL/min.
- Signed written informed consent.
Exclusion
- 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.
- Pregnant or nursing women.
- Acute infection requiring intravenous antibiotics.
- Severe vomiting or medical condition which could interfere with oral medication intake.
- Anticonvulsant chronic therapy.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2006
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00831545
Start Date
December 1 2000
End Date
October 20 2006
Last Update
May 9 2017
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