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NCT00003222 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
A Phase 2 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00003222: Completed Phase 2 study, sponsored by University of Virginia.
NCT00003222 is a Phase 2 study that has completed, run by University of Virginia. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003222, a Phase 2 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.
Primary Outcome
The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in
Interventions
- BIOLOGICAL aldesleukin
- BIOLOGICAL sargramostim
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL gp100 antigen
- BIOLOGICAL tetanus peptide melanoma vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1998-04 |
| Phase | Phase 2 |
What the finished NCT00003222 record still lists
NCT00003222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which aldesleukin is the first listed.
NCT00003222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003222 about?
NCT00003222 is a clinical study titled "Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma". RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to...
What is the current status of trial NCT00003222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 1998-04.
What interventions are being tested in trial NCT00003222?
The interventions under investigation include: aldesleukin (BIOLOGICAL), sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), tetanus peptide melanoma vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003222?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003222's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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