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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). 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.
Primary Outcome
Tumor assessments using irRC modified World Health Organizations (WHO) criteria: Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions. Immune-Related Partial Response (irPR): decrease of 50% or greater. Immune-Related Progressive Disease (irPD): At least 25% increase in sum of products of all index lesions over baseline sum of products of diameters (SPD) calculated for index lesions. Assessment include photographic measurement of skin lesions, computed tomography
Interventions
- DRUG Cisplatin
- DRUG Ipilimumab
- DRUG Temozolomide
- DRUG Interleukin-2
- DRUG Interferon Alfa-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Why NCT01409174 stopped before completion
NCT01409174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01409174 does not publish any study locations in the registry export this page uses.
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: Cisplatin (DRUG), Ipilimumab (DRUG), Temozolomide (DRUG), Interleukin-2 (DRUG), Interferon Alfa-2b (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01409174's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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