Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT01164709|
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : February 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Mature T-cell and Nk-cell Neoplasms Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib Drug: nelfinavir mesylate||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies|
|Study Start Date :||July 2010|
|Primary Completion Date :||July 2012|
|Study Completion Date :||November 2013|
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
- Dose limiting toxicity [ Time Frame: during first cycle ]
- Objective response [ Time Frame: during treatment ]
- Adverse events according to NCI CTCAE v.4.0 [ Time Frame: during treatment + 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164709
|Bern, Switzerland, CH-3010|
|Chur, Switzerland, CH-7000|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Study Chair:||Christoph Driessen, MD||Cantonal Hospital of St. Gallen|
|Principal Investigator:||Dagmar Hess, MD||Cantonal Hospital of St. Gallen|
|Principal Investigator:||Roger von Moos, MD||Kantonsspital Graubuenden|
|Principal Investigator:||Thomas Pabst, MD||University Hospital Inselspital, Berne|