Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01369875 · ClinicalTrials.gov registry record · Phase 2
Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01369875: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01369875 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369875, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue. The cells are modified to help them kill tumor cells, then given back to the person with cancer. By giving these cells to patients, researchers hope to improve the current treatments available for patients with melanoma that has not responded to standard therapies. The TIL will be given after treatments that will suppress the immune system. This makes it easier for the TIL to attack the cancer cells. The TIL will also be given with aldesleukin (IL-2), which is designed to help keep the TIL cells alive in the body. Objectives: \- To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes to treat melanoma that has not responded to other treatments. Eligibility: \- Individuals at least 18 years of age who have metastatic melanoma that has not responded to other treatments. Design: * Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies. * A piece of tumor will be collected and white blood cells will be separated to make the TIL for the treatment. * Participants will take drugs to suppress the immune system for 7 days before the start of treatment. * Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8 hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks after treatment. They will be monitored with frequent blood tests and other studies. * After leaving the hospital, participants will have regular followup visits every 1 to 4 months for the first year. Then they will return for followup every 3 to 4 months, as directed by the study researchers.
Primary Outcome
Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or mo
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Tumor Infiltrating Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-06-17 |
| Est. Completion | 2012-02-14 |
| Phase | Phase 2 |
Why NCT01369875 stopped before completion
NCT01369875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01369875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369875 about?
NCT01369875 is a clinical study titled "Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma". Background: \- Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue. The cells are modified to help them kill tumor cells, then given back to the person with cancer. By giving these cells to patients, researchers hope to improve the current treatments av...
What is the current status of trial NCT01369875?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-06-17. Estimated completion is 2012-02-14.
What interventions are being tested in trial NCT01369875?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (BIOLOGICAL), Tumor Infiltrating Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01369875?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369875's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI