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NCT01100528 · ClinicalTrials.gov registry record · Phase 2
Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
A Phase 2 study of Iris Melanoma and Ciliary Body and Choroid Melanoma, Medium/Large Size, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01100528: Completed Phase 2 study of Iris Melanoma and Ciliary Body and Choroid Melanoma, Medium/Large Size, sponsored by Case Comprehensive Cancer Center.
NCT01100528 is a Phase 2 study of Iris Melanoma and Ciliary Body and Choroid Melanoma, Medium/Large Size that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01100528, a Phase 2 study of Iris Melanoma and Ciliary Body and Choroid Melanoma, Medium/Large Size, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal melanoma. PURPOSE: This phase II trial is studying how well giving dacarbazine together with recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with genetic imbalance.
Primary Outcome
DFS will be calculated from the date treatment starts to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier. Treatment will be considered relatively ineffective in this population if the underlying 2-year DFS is \<60%, whereas the combination will be considered promising if the underlying rate is \>80%.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG dacarbazine
- BIOLOGICAL recombinant interferon alfa-2b
Study Locations (1)
Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2009-11-11 |
| Est. Completion | 2017-12-14 |
| Phase | Phase 2 |
What the finished NCT01100528 record still lists
NCT01100528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 4 conditions, with Iris Melanoma appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01100528 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01100528 about?
NCT01100528 is a clinical study titled "Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance". RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with da...
What is the current status of trial NCT01100528?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-11-11. Estimated completion is 2017-12-14.
What conditions does trial NCT01100528 study?
This clinical trial studies the following conditions: Iris Melanoma, Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Recurrent Intraocular Melanoma.
What interventions are being tested in trial NCT01100528?
The interventions under investigation include: laboratory biomarker analysis (OTHER), dacarbazine (DRUG), recombinant interferon alfa-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT01100528?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01100528 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01100528's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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