Conditions: Brain and Central Nervous System Tumors Melanoma Solid Tumor
Keywords: stage III melanoma stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific recurrent adult brain tumor melanoma (skin)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 47
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide together with bortezomib may kill more tumor cells.

PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they work in treating patients with advanced refractory solid tumors or melanoma.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PS-341 (VELCADE) intervention 2: temozolomide intervention 3: immunoenzyme technique intervention 4: PS-341 (VELCADE) intervention 5: Temozolomide
Intervention descriptions: intervention 1: Dose Levels PS-341 (day 1)

* Level -1 0.7 mg/m2
* Level 1 1.0 mg/m2
* Level 2 1.0 mg/m2
* Level 3 1.3 mg/m2
* Level 4 1.5 mg/m2 intervention 2: Temozolomide (day 8)

* Level - 1 50 mg/m2
* Level 1 50 mg/m2
* Level 2 75/mg/m2
* Level 3 75 mg/m2
* Level 4 75 mg/m2 intervention 3: Not noted intervention 4: 1.3 mg/m2 by IV on days 1, 4, 8, and 11 of every 21 days intervention 5: 75 mg/m2 by mouth, daily, during weeks 2-8 (42 days) of every 9-week course.

Protocol document: