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NCT00665470 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00665470: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00665470 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665470, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: This study uses a new experimental procedure for treating melanoma that uses the patient's own lymphocytes (type of white blood cell), which are specially selected to target and destroy their tumor. Objectives: To determine whether this experimental treatment can cause the patient's tumor to shrink. To test the safety of the treatment and its effects on the immune system. Eligibility: Patients with metastatic melanoma 18 years of age and older for whom standard treatments are not effective or who cannot take high-dose interleukin-2 (IL-2). Patients must have the tissue type human leukocyte antigens (HLA-A)0201. Design: Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed. Patients have leukapheresis (a procedure for collecting lymphocytes that is similar to collecting whole blood) to collect cells for laboratory treatment and later reinfusion. Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to receive the cultured lymphocytes. Cell infusion and IL-2 treatment: Patients receive the lymphocytes by infusion through a vein and then either high-dose IL-2 infused through a vein or low-dose IL-2 injected under the skin. High-dose IL-2 is given as infusions through a vein every 8 hours for up to 15 doses. Low-dose IL-2 is given as injections under the skin daily for 5 days, followed by a 2-day rest, with this regimen repeated for a total of 5 weeks. Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and IL-2. Tumor biopsy: Patients may be asked to have a biopsy (removal of a small piece of tumor) after receiving treatment to look at the effects of treatment in the tumor. Follow-up: After treatment is completed, patients return to the clinic for physical examinations, review of side effects, laboratory tests and scans every 1 to 6 months until the disease worsens. Retreatment: Patients whose tumor did not grow after treatment or showed evidence
Interventions
- DRUG Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00665470
The ClinicalTrials.gov registry entry for NCT00665470 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aldesleukin is the first listed.
NCT00665470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00665470 about?
NCT00665470 is a clinical study titled "Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma". Background: This study uses a new experimental procedure for treating melanoma that uses the patient's own lymphocytes (type of white blood cell), which are specially selected to target and destroy their tumor. Objectives: To determine whether this experimental treatment can cause the patient's t...
What is the current status of trial NCT00665470?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00665470?
The interventions under investigation include: Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT00665470?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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