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NCT01550367 · ClinicalTrials.gov registry record · Phase 1
Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)
A Phase 1 study, sponsored by Leonard Appleman.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01550367: Completed Phase 1 study, sponsored by Leonard Appleman.
NCT01550367 is a Phase 1 study that has completed, run by Leonard Appleman. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01550367, a Phase 1 study, has completed, sponsored by Leonard Appleman.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progress
Interventions
- DRUG IL-2
- DRUG Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-03 |
| Est. Completion | 2019-02 |
| Phase | Phase 1 |
What the finished NCT01550367 record still lists
NCT01550367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which IL-2 is the first listed.
NCT01550367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01550367 about?
NCT01550367 is a clinical study titled "Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)". 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 i...
What is the current status of trial NCT01550367?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-03. Estimated completion is 2019-02.
What interventions are being tested in trial NCT01550367?
The interventions under investigation include: IL-2 (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT01550367?
This trial is sponsored by Leonard Appleman, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01550367's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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