Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Northwestern Memorial Hospital
• Treatments: Dacarbazine; Temozolomide; Vinblastine; Vinorelbine

Criteria

INCLUSION CRITERIAL:

• Age > or = 18 years.

• Karnofsky performance score > or = 60.

• Histopathologic confirmation of the diagnosis of a solid tumor malignancy. The brain metastasis diagnosis per se does not have to be pathologically confirmed if the clinical and neuro radiographic picture is typical.

• MRI (or CT if the patient cannot undergo MRI) evidence of evaluable disease in the brain.

• Absolute neutrophil count > or = 1,500/mm³. Platelet count > or = 100,000/mm³.

• Hemoglobin > or = 10 g/dl.

• BUN and serum creatinine both < 1.5 times upper limit of normal.

• Total and direct bilirubin both < 1.5 times upper limit of normal.

• SGOT and SGPT both < or = 3 times upper limit of normal.

• Alkaline phosphatase < or = 2 times upper limit of normal.

• At least two weeks must have elapsed from brain biopsy, craniotomy, or other surgery.

• Life expectancy > or = 8 weeks.

• Patient or their legal guardian or legal next-of-kin must provide written informed consent prior to patient's registration on study.

• At least four weeks must have elapsed from previous external beam radiation therapy, or eight weeks from stereotactic radiosurgery.

• Patients treated with radiosurgery should have evidence of progression at a distant site in the brain, or confirmation of tumor progression by biopsy or PET scan.

EXCLUSION CRITERIA:

• Previous treatment with temozolomide, dacarbazine or vinorelbine.

• Patients who have not recovered from all acute toxicities of prior therapies.

• Patients with evidence of leptomeningeal metastases or primary dural metastases.

• Patients who are poor medical risks because of nonmalignant systemic disease, as well as those with acute infection requiring treatment with intravenous antibiotics.

• Patients whose psychiatric condition would, in the judgment of the principal investigator, make it unlikely that they could adhere to the requirements of the protocol.