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NCT01124734 · ClinicalTrials.gov registry record · Phase 2
High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
A Phase 2 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01124734 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 17 participants.
The verdict
NCT01124734, a Phase 2 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The investigators have observed that many patients who had received high dose Interleukin-2 (IL2) and failed to respond to it but who then go immediately to temozolomide seemed to enjoy extremely good responses which seem better quality and longer duration than typically observed for temozolomide alone. To date, the investigators have observed 5 sequentially treated patients with metastatic melanoma who had failed high dose IL-2 but who then went on to receive immediate temozolomide. Two of these patients had complete responses and 3 had very strong partial response. In a recent phase II study of extended low dose temozolomide alone given in the same manner as the post IL-2 patients noted above, the response rate was 12.5% and all of these were partial responses only. The responses that the investigators observed were at a much higher rate of response as well as much better quality than expected for temozolomide. The responses were also better than those observed when temozolomide was given first and then followed by high dose IL-2. The investigators concluded that perhaps the major benefit the investigators observed was a result of the prior high dose IL-2 therapy modulated by the temozolomide and that the sequence of treatment was clearly crucial for this response.
Interventions
- DRUG Temozolomide
- DRUG Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-05 |
| Est. Completion | 2018-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01124734
The ClinicalTrials.gov registry entry for NCT01124734 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT01124734 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01124734 about?
NCT01124734 is a clinical study titled "High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma". The investigators have observed that many patients who had received high dose Interleukin-2 (IL2) and failed to respond to it but who then go immediately to temozolomide seemed to enjoy extremely good responses which seem better quality and longer duration than typically observed for temozolomide al...
What is the current status of trial NCT01124734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-05. Estimated completion is 2018-07-01.
What interventions are being tested in trial NCT01124734?
The interventions under investigation include: Temozolomide (DRUG), Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT01124734?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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