Determine Toxicity and Antibody Responses With a KLH Conjugated Bivalent Vaccine Containing GD2 Lactone, GD3 Lactone With Immunological Adjuvant QS-DG or OPT-821 in Patients With Disease Free AJCC Stage III or IV Cutaneous Melanoma
Public ClinicalTrials.gov record NCT00597272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Trials With a KLH Conjugated Bivalent GangliosideVaccine Mixed With Immunological Adjuvants QS-DG or OPT-821in Patients With Disease Free AJCC Stage III or IV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Vaccines contain substances that help us make antibodies. Different antibodies help protect us against a variety of harmful things. GD2 and GD3 gangliosides are substances found on the surface of most melanoma cells. They are also occasionally found on some normal cells. Large quantities of antibodies called monoclonal antibodies have been prepared in the laboratory against GD2 and GD3 and given to patients with metastatic melanoma. In about 10% of cases this has resulted in clinically relevant regression of melanomas. These monoclonal antibodies are not currently available or used in the clinic but studies in the laboratory indicate that vaccines against GD2 and GD3 can be as effective as monoclonal antibodies. In this trial we wish to raise the level of antibodies in your blood against GD2 and GD3. We will vaccinate you with the modified forms of GD2 called GD2 lactone and GD3 called GD3 lactone (GD3L), all attached to the antibody booster KLH, and mixed with the immune booster (immunologic adjuvant) QS-DG. While over a thousand patients have received vaccines with QS-21, the QS-DG used here is synthesized for the first time at MSKCC and is referred to as QS-DG rather than QS-21 which is purified from tree bark. QS-21 and QS-DG are, to the best of our knowledge chemically identical. It is unknown if using this bivalent vaccine will raise the level of antibodies in your blood to either ganglioside. It is unknown if raising the level of antibodies in your blood will lower your risk of relapse. This study will check your blood for production of antibodies, and check you for side effects.
Study identification
- NCT ID
- NCT00597272
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 34 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2007
- Primary completion
- Oct 31, 2012
- Completion
- Oct 31, 2012
- Last update posted
- Sep 19, 2016
2007 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00597272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2016 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00597272 live on ClinicalTrials.gov.