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Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
NCT00118274 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL melanoma helper peptide vaccine
- BIOLOGICAL multi-epitope melanoma peptide vaccine
- BIOLOGICAL tetanus toxoid helper peptide
Study Locations (3)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia — Philadelphia
Texas
- M. D. Anderson Cancer Center at University of Texas — Houston
Virginia
- University of Virginia Cancer Center — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00118274
The ClinicalTrials.gov registry entry for NCT00118274 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Craig L Slingluff, Jr, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions — of which cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00118274 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Texas, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00118274 about?
NCT00118274 is a clinical study titled "Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophospha...
What is the current status of trial NCT00118274?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2005-03. Estimated completion is 2010-02.
What conditions does trial NCT00118274 study?
This clinical trial studies the following conditions: Melanoma (Skin). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00118274?
The interventions under investigation include: cyclophosphamide (DRUG), incomplete Freund's adjuvant (BIOLOGICAL), melanoma helper peptide vaccine (BIOLOGICAL), multi-epitope melanoma peptide vaccine (BIOLOGICAL), tetanus toxoid helper peptide (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00118274?
This trial is sponsored by Craig L Slingluff, Jr, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00118274 being conducted?
This trial has 3 study locations across Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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