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NCT01807182 · ClinicalTrials.gov registry record · Phase 2
Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01807182: Completed Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by Fred Hutchinson Cancer Center.
NCT01807182 is a Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 11 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807182, a Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination chemotherapy works in treating patients with melanoma that has spread to other places in the body. Biological therapies, such as TIL, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TIL after combination chemotherapy may kill more tumor cells.
Primary Outcome
Assessed using Response Evaluation Criteria in Solid Tumors 1.1 definitions for complete response, partial response, stable disease, and progressive disease. Clinical response will be determined at 6 weeks, 12 weeks and 24 weeks based on RECIST version 1.137 definitions for Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). Response reported is best response per participant. A complete response will be defined as total regression of all tumors, a PR
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Therapeutic Tumor Infiltrating Lymphocytes
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-08-20 |
| Est. Completion | 2021-08-26 |
| Phase | Phase 2 |
What the finished NCT01807182 record still lists
NCT01807182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01807182 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01807182 about?
NCT01807182 is a clinical study titled "Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma". This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination chemotherapy works in treating patients with melanoma that has spread to other places in the body. Biological therapies, such as TIL, may stimulate the immune system in different ways and stop tumor cells fro...
What is the current status of trial NCT01807182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2013-08-20. Estimated completion is 2021-08-26.
What conditions does trial NCT01807182 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage III Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT01807182?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Aldesleukin (BIOLOGICAL), Therapeutic Tumor Infiltrating Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01807182?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01807182 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01807182's enrollment target sits among peer trials
11 87th of 91 higher than 5 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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