NCT00580320

Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

Detailed description

The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly. Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Conditions

• Melanoma
• Soft Tissue Sarcoma
• Parathyroid Carcinoma
• Small Cell Carcinoma of the Lung
• Carcinoid Tumors

Interventions

Type	Name	Description
DRUG	Dacarbazine and bortezomib	Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-10-01
• Completion: 2013-11-01
• First posted: 2007-12-24
• Last updated: 2016-08-18

Locations

2 sites across 1 country: United States