Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer
RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with bortezomib in treating patients with relapsed or progressive advanced hematologic cancer.
Mature T-cell and Nk-cell Neoplasms
Multiple Myeloma and Plasma Cell Neoplasm
Drug: nelfinavir mesylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies|
- Dose limiting toxicity [ Time Frame: during first cycle ] [ Designated as safety issue: Yes ]
- Objective response [ Time Frame: during treatment ] [ Designated as safety issue: No ]
- Adverse events according to NCI CTCAE v.4.0 [ Time Frame: during treatment + 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: bortezomib + nelfinavir
escalation 3 by 3 cohorts
Bortezomib i.v., day 8, 11, 15, 18; 1.3 mg/m2
Other Name: VelcadeDrug: nelfinavir mesylate
p.o., days 1 to 21; dose level: (625), 1250, 1875, or 2500 mg, 2x/d
Other Name: Viracept
- To assess the safety of nelfinavir mesylate in combination with bortezomib in patients with relapsed or progressive, advanced hematologic malignancies.
- To establish the phase II recommended dose of nelfinavir mesylate in these patients.
OUTLINE: This is a multicenter, dose-escalation study of nelfinavir mesylate.
Patients receive oral nelfinavir mesylate twice daily on days 1-21 and bortezomib IV on days 8, 11, 15, and 18 in course 1. Course 1 has a duration of 28 days. Beginning in course 2, patients receive oral nelfinavir mesylate twice daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for 2 courses. Patients with responding disease may continue to receive nelfinavir mesylate and bortezomib for up to 4 additional courses.
After completion of study treatment, patients are followed for 30 days.
|Bern, Switzerland, CH-3010|
|Contact: Thomas Pabst, Prof. 41-31-632-8430 firstname.lastname@example.org|
|Chur, Switzerland, CH-7000|
|Contact: Roger von Moos, MD 41-81-256-6111 email@example.com|
|Centre Hospitalier Universitaire Vaudois||Recruiting|
|Lausanne, Switzerland, CH-1011|
|Contact: Grégoire Berthod, MD +41 21 314 01 55 Gregoire.firstname.lastname@example.org|
|Kantonsspital - St. Gallen||Recruiting|
|St. Gallen, Switzerland, CH-9007|
|Contact: Christoph Driessen, MD 41-71-494-1162 email@example.com|
|Study Chair:||Christoph Driessen, MD||Kantonsspital St. Gallen|
|Principal Investigator:||Dagmar Hess, MD||Kantonsspital St. Gallen|
|Principal Investigator:||Roger von Moos, MD||Kantonsspital Graubuenden|
|Principal Investigator:||Thomas Pabst, MD||University Hospital Inselspital, Berne|