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NCT01409174 · ClinicalTrials.gov registry record · Phase 1
IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01409174: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01409174 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409174, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Note: The study was closed following Phase I enrollment. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer. Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells. Cisplatin is designed to poison the cancer cells, which may cause them to die.
Interventions
- DRUG Ipilimumab
- DRUG Temozolomide
- DRUG Cisplatin
- DRUG Interferon Alfa-2b
- DRUG Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01409174
The ClinicalTrials.gov registry entry for NCT01409174 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ipilimumab is the first listed.
NCT01409174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01409174 about?
NCT01409174 is a clinical study titled "IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma". The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastat...
What is the current status of trial NCT01409174?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2013-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01409174?
The interventions under investigation include: Ipilimumab (DRUG), Temozolomide (DRUG), Cisplatin (DRUG), Interferon Alfa-2b (DRUG), Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT01409174?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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