Clinical Trials Directory

Trials / Completed

CompletedNCT02240719

Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer

Phase I Study of Everolimus + Bendamustine in Patients With Relapsed/Refractory Hematological Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and the best dose of everolimus when given together with bendamustine hydrochloride in treating patients with cancer of the blood (hematologic cancer) that has returned after a period of improvement (relapsed) or did not get better with a particular treatment (refractory). Everolimus may prevent cancer cells from growing by blocking a protein that is needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with bendamustine hydrochloride may be a better treatment for hematologic cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of everolimus when administered in combination with bendamustine (bendamustine hydrochloride) in defined hematologic malignancies. II. To determine the safety and tolerability of administering everolimus in combination with bendamustine chemotherapy. SECONDARY OBJECTIVES: I. To determine the efficacy of everolimus when administered in combination with bendamustine in adult patients with relapsed/refractory hematological malignancies. OUTLINE: This is a dose-escalation study of everolimus. Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2 and everolimus orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

Interventions

TypeNameDescription
DRUGeverolimusGiven PO
DRUGbendamustine hydrochlorideGiven IV

Timeline

Start date
2014-10-01
Primary completion
2018-04-09
Completion
2018-04-09
First posted
2014-09-16
Last updated
2019-01-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02240719. Inclusion in this directory is not an endorsement.