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NCT01266603 · ClinicalTrials.gov registry record · Phase 2
High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01266603: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01266603 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266603, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be studied. Researchers will also use samples of the original tumor or metastatic tissue (for example, lymph nodes or liver or lung) that are collected during screening to study if response to the study drug is related to the genes in the tissue.
Primary Outcome
To evaluate the objective response rate induced by the concurrent administration of HDIL-2 and recMAGE-A3 + AS15 ASCI in patients with MAGE-A3-positive, unresectable or metastatic melanoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- DRUG HDIL-2
- BIOLOGICAL recMAGE-A3 + AS15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-02-22 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 2 |
What the finished NCT01266603 record still lists
NCT01266603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which HDIL-2 is the first listed.
NCT01266603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01266603 about?
NCT01266603 is a clinical study titled "High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI". The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein....
What is the current status of trial NCT01266603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-02-22. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT01266603?
The interventions under investigation include: HDIL-2 (DRUG), recMAGE-A3 + AS15 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01266603?
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 NCT01266603's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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