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

Phase 1

Terminated

• Conditions: Brain and Central Nervous System Tumors; Melanoma; Solid Tumor
• Interventions: Drug: PS-341 (VELCADE); Drug: Temozolomide; Other: immunoenzyme technique

• Registration Number: NCT00512798
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-07
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-08
• Study Completion: 2008-03
• Results First Submitted: 2012-06-27
• Results First Submitted QC: 2012-06-27
• Results First Posted: 2012-08-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-19
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I	PS-341 (VELCADE)	-
Phase I	Temozolomide	-
Phase I	immunoenzyme technique	-
Phase II	PS-341 (VELCADE)	-
Phase II	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
Optimal Doses of Temozolomide and Bortezomib (Phase I)	up to 42 days	The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide
Number of Patients With Clinical Anti-tumor Activity Phase II)	every 9 weeks to a maximum of 54 weeks	Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD

Secondary Outcome Measures

Name	Time	Method
Patients With Inhibition in NF-kB Activation (Phase I)	at baseline, on day 8 and on day 29	Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells
Patients With Clinical Anti-tumor Activity (Phase I)	every 9 weeks up to a maximum of 54 weeks	Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Patients With Inhibition of NF-kB (Phase II)	at baseline, on day 8 and on day 29	Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States