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Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-Small Cell Lung Cancer.

Phase 2
18 Years
70 Years
Not Enrolling
Metastases of Central Nervous System, Melanoma, Breast Neoplasm, Carcinoma, Non-Small-Cell Lung

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Trial Information

Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-Small Cell Lung Cancer.

Inclusion Criteria:

- Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and

- 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

- 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 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

- Anticonvulsant chronic therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best response related to brain metastases observed during the study period.

Outcome Time Frame:

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.

Safety Issue:



Italy: Ministry of Health

Study ID:




Start Date:

December 2000

Completion Date:

October 2006

Related Keywords:

  • Metastases of Central Nervous System
  • Melanoma
  • Breast Neoplasm
  • Carcinoma, Non-Small-Cell Lung
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Melanoma
  • Neoplasm Metastasis