MedTrace Logo

Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)

NCT01550367 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-02

Study results available
· View outcomes & findings →

Summary

The main goal of the research study is to determine whether treating renal cell cancer patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of kidney cancer that has spread to other parts of the body, can make the cancer easier to kill and eliminate. Another goal is to see how the study drug affects the body's immune cells which fight cancer cells.

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Hydroxychloroquine

Continuous oral administration (at 600 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

DRUG

IL-2

600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Sponsors & Collaborators

  • Prometheus Laboratories

    collaborator INDUSTRY

  • Leonard Appleman

    lead OTHER

Principal Investigators

  • Leonard J Appleman, MD, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2018-02-06
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550367 on ClinicalTrials.gov