NCT00512798

Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma

(Inhibition of NF-kB Signaling in Melanoma Therapy) A Phase I/II Clinical Trial of PS-341, a Proteasome Inhibitor, in Combination With an Extended Continuous Oral Schedule of Temozolomide in Patients With Advanced Refractory Solid Tumors With the Phase II Component Only in Patients With Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors
• Melanoma
• Solid Tumor

Interventions

Type	Name	Description
DRUG	PS-341 (VELCADE)	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
DRUG	temozolomide	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
OTHER	immunoenzyme technique	Not noted
DRUG	PS-341 (VELCADE)	1.3 mg/m2 by IV on days 1, 4, 8, and 11 of every 21 days
DRUG	Temozolomide	75 mg/m2 by mouth, daily, during weeks 2-8 (42 days) of every 9-week course.

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-07-01
• Completion: 2008-03-01
• First posted: 2007-08-08
• Last updated: 2012-10-02
• Results posted: 2012-08-03

Locations

1 site across 1 country: United States