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NCT01271907 · ClinicalTrials.gov registry record · Phase 2
Drosophila-generated CTL
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01271907: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01271907 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 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
NCT01271907, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Recent cancer treatment studies have shown that altering a cancer patient's own white blood cells may help the immune system fight the cancer. In all of these studies, participants donate their own white blood cells through a procedure called leukapheresis, and the cells are altered in the laboratory and given back to the participants. After the cells are given, the patients receive aldesleukin (IL-2) to help the tumor fighting cells stay alive longer. For individuals with metastatic melanoma, pieces of melanoma proteins may be added to the collected white blood cells to help the immune system recognize and attack the cancer cells. * Researchers are interested in testing a new process in which cells from fruit flies (Drosophila) are used to help the melanoma proteins attach to the white blood cells. The fruit fly cells die off shortly after the proteins are introduced to the white blood cells. Researchers are also interested in determining whether IL-2 treatment is necessary after this new cancer treatment process. Objectives: * To test the safety and effectiveness of modified white blood cells (Drosophila-generated CTL) as a treatment for metastatic melanoma that has not responded to standard treatments. * To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated cytolytic T lymphocytes (CTL). Eligibility: \- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that has not responded to previous IL-2 treatment. Design: * Participants will be screened with a physical examination and medical history, tumor imaging studies, and heart and lung function tests. * Prior to treatment, participants will have an intravenous catheter inserted into the chest to administer the study drugs. * Participants will have leukapheresis to provide white blood cells for laboratory modification. * Seven days before the start of the treatment, participants will be admitted to the hospital to have chemotherap
Primary Outcome
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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 disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance
Interventions
- DRUG Aldesleukin
- DRUG fludarabine
- DRUG cyclophosphamide
- DRUG Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-04-15 |
| Est. Completion | 2011-12-08 |
| Phase | Phase 2 |
Why NCT01271907 stopped before completion
NCT01271907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 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 Aldesleukin is the first listed.
NCT01271907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01271907 about?
NCT01271907 is a clinical study titled "Drosophila-generated CTL". Background: * Recent cancer treatment studies have shown that altering a cancer patient's own white blood cells may help the immune system fight the cancer. In all of these studies, participants donate their own white blood cells through a procedure called leukapheresis, and the cells are altered i...
What is the current status of trial NCT01271907?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-04-15. Estimated completion is 2011-12-08.
What interventions are being tested in trial NCT01271907?
The interventions under investigation include: Aldesleukin (DRUG), fludarabine (DRUG), cyclophosphamide (DRUG), Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (DRUG).
Who is sponsoring clinical trial NCT01271907?
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 NCT01271907's enrollment target sits among peer trials
3 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
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