CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Hydroxychloroquine +1 moredrug
Likely dose
Hydroxychloroquine 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01550367
NCT01550367Phase 2Completed

Inhibiting the Systemic Autophagic Syndrome - A Phase I/II Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC). A Cytokine Working Group (CWG) Study

Leonard Appleman·interventional·Posted Mar 12, 2012·Updated Jan 2, 2020

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine and IL-2 for Metastatic Renal Cell Carcinoma. Completed, enrolled 30 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2012
Enrollment StartMar 1, 2012
Primary CompletionFeb 6, 2018
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.3 years ago

Interventions

Hydroxychloroquinedrug

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.

IL-2drug

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