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Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
NCT00006385 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Conditions Studied
Interventions
- BIOLOGICAL recombinant interferon alfa
- BIOLOGICAL sargramostim
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL gp100 antigen
- BIOLOGICAL MART-1 antigen
Study Locations (20)
Illinois
- Veterans Affairs Medical Center - Lakeside Chicago — Chicago
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University — Chicago
- CCOP - Evanston — Evanston
- CCOP - Carle Cancer Center — Urbana
Georgia
- Emory University Hospital - Atlanta — Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur) — Decatur
Indiana
- Indiana University Cancer Center — Indianapolis
- Veterans Affairs Medical Center - Indianapolis (Roudebush) — Indianapolis
Massachusetts
- Tuft-New England Medical Center — Boston
- Beth Israel Deaconess Medical Center — Boston
New Jersey
- CCOP - Northern New Jersey — Hackensack
- Cancer Institute of New Jersey — New Brunswick
Arizona
- CCOP - Scottsdale Oncology Program — Scottsdale
Iowa
- CCOP - Iowa Oncology Research Association — Des Moines
Kansas
- CCOP - Wichita — Wichita
Trial Details
| Field | Value |
|---|---|
| Start Date | 2000-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006385
The ClinicalTrials.gov registry entry for NCT00006385 describes a study currently listed as completed. It is categorized as Phase 2, 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. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Eastern Cooperative Oncology Group, which has 30 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 recombinant interferon alfa 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: NCT00006385 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Illinois, Georgia, Indiana. 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 NCT00006385 about?
NCT00006385 is a clinical study titled "Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or wit...
What is the current status of trial NCT00006385?
This trial is currently completed. It is a Phase 2 study. The study started on 2000-09.
What conditions does trial NCT00006385 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 NCT00006385?
The interventions under investigation include: recombinant interferon alfa (BIOLOGICAL), sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00006385?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00006385 being conducted?
This trial has 20 study locations across Arizona, Georgia, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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