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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)

Phase 2
Completed
Conditions
Metastases of Central Nervous System
Melanoma
Breast Neoplasm
Carcinoma, Non-Small-Cell Lung
Interventions
Registration Number
NCT00831545
Lead Sponsor
Merck Sharp & Dohme LLC
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 enrolled. If \>=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if \>=10 patients will respond. If \<2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
162
Inclusion Criteria
  • 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.
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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Subjects with non-small cell lung cancerTemozolomide-
Subjects with breast cancerTemozolomide-
Subjects with melanomaTemozolomide-
Primary Outcome Measures
NameTimeMethod
Best response related to brain metastases observed during the study period.After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.
Secondary Outcome Measures
NameTimeMethod
Progression-free survival, brain progression-free survival, and overall survival.After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.
Adverse events according to NCI CTC grading system of toxicity.Throughout the study.
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