Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer

Phase 1

Completed

• Conditions: Mature T-cell and Nk-cell Neoplasms; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Leukemia
• Interventions: Drug: bortezomib; Drug: nelfinavir mesylate

• Registration Number: NCT01164709
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-19
• Primary Completion: 2012-07
• Study Completion: 2013-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bortezomib + nelfinavir	nelfinavir mesylate	escalation 3 by 3 cohorts
bortezomib + nelfinavir	bortezomib	escalation 3 by 3 cohorts

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	during first cycle

Secondary Outcome Measures

Name	Time	Method
Objective response	during treatment
Adverse events according to NCI CTCAE v.4.0	during treatment + 30 days

Trial Locations

Locations (4)

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland