MelanomaNCT00597272
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
A study testing KLH conjugates with GD2L and GD3L in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- KLH conjugates with GD2L and GD3L
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 with AJCC stage III or IV melanoma two weeks to one year after becoming clinically free of disease will be eligible.
- For all patients' pathology slides must be reviewed by the Memorial Hospital Department of Pathology to confirm diagnosis of cutaneous melanoma.
- All patients must have a Karnofsky performance status of ≥80.
- Patients may have received previous radiation, chemotherapy or systemic immunotherapy (completed at least 4 weeks prior to vaccination).
- A CBC must be performed within 2 weeks prior to vaccination with the WBC > or equal to 3.0 cells/mm3, Platelets >100,000/mm3,
- A screening profile must be performed within 2 weeks prior to vaccination with the total bilirubin ≤ 2.0, and other LFTs within normal limits for patient's age.
- Chest, abdomen and pelvic CT or MRI must be performed within 4 weeks of the initiation of treatment showing no evidence of disease.
- Women of child bearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment.
Who cannot join
- Patients previously treated with KLH or ganglioside containing vaccines, or monoclonal antibodies against gangliosides are not eligible.
- Women must not be pregnant (negative βHCG within 2 weeks of vaccination if of childbearing potential).
- Patients with other active cancers within the past 2 years, (excluding basal cell, squamous carcinomas of the skin or cervical carcinoma-in-situ) are not eligible.
- Any medical condition which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them is grounds for exclusion, at the discretion of the Principal Investigator.
- Patients requiring anti-inflammatory medications such a steroids, NSAIDS or full dose aspirin are not eligible.
- There must be no evidence of metastatic disease at the time of the first vaccine. However, patients who develop new metastases during treatment may continue on treatment as long as no systemic treatment is indicated and any local treatment such as surgical resection or radiation would not cause a delay in vaccination or two weeks or more.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
- Conditions
- Melanoma
- Being tested
- KLH conjugates with GD2L and GD3L
- Keywords
- melanoma, resected local, systemic metastasis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLH conjugates with GD2L and GD3LBiological
6 vaccinations (on weeks 1, 2, 3, 8, 20 and 32) which will contain the same KLH conjugates with GD2L and GD3L. All vaccines contain KLH conjugates containing 30mcg of GD2L and 30mcg of GD3L and QS-DG or OPT-821. The initial 8 patients will receive the same QS-DG or OPT-821 vaccine dose in all of their vaccines. This dose will be 50 mcg for the first patient, 75 mcg for the second patient and 100 mcg for the third through eighth patients. In all subsequent patients the 1st, 4th and 5th vaccinations will include 150 mcg of OPT-821. The 2nd and 3rd vaccinations will contain 100 mcg of OPT-821 and the 6th vaccination will contain 200 mcg of OPT-821.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vaccine- KLH conjugates with GD2L and GD3L Receives: Biological: KLH conjugates with GD2L and GD3L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Chapman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597272
- Sponsor's protocol ID
- 06-086
- Status last verified
- Aug 2016
- First submitted
- 8 Jan 2008
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00597272
- Acronym / sponsor ID
- 06-086
- Conditions
- Melanoma
- Keywords
- melanoma, resected local, systemic metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Posted 10 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: KLH conjugates with GD2L and GD3LVaccine- KLH conjugates with GD2L and GD3L |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥18 with AJCC stage III or IV melanoma two weeks to one year after becoming clinically free of disease will be eligible.
- For all patients' pathology slides must be reviewed by the Memorial Hospital Department of Pathology to confirm diagnosis of cutaneous melanoma.
- All patients must have a Karnofsky performance status of ≥80.
- Patients may have received previous radiation, chemotherapy or systemic immunotherapy (completed at least 4 weeks prior to vaccination).
- A CBC must be performed within 2 weeks prior to vaccination with the WBC > or equal to 3.0 cells/mm3, Platelets >100,000/mm3,
Key exclusion criteria (6 listed)
- Patients previously treated with KLH or ganglioside containing vaccines, or monoclonal antibodies against gangliosides are not eligible.
- Women must not be pregnant (negative βHCG within 2 weeks of vaccination if of childbearing potential).
- Patients with other active cancers within the past 2 years, (excluding basal cell, squamous carcinomas of the skin or cervical carcinoma-in-situ) are not eligible.
- Any medical condition which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them is grounds for exclusion, at the discretion of the Principal Investigator.
- Patients requiring anti-inflammatory medications such a steroids, NSAIDS or full dose aspirin are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLH conjugates with GD2L and GD3L6 vaccinations (on weeks 1, 2, 3, 8, 20 and 32) which will contain the same KLH conjugates with GD2L and GD3L. All vaccines contain KLH conjugates containing 30mcg of GD2L and 30mcg of GD3L and QS-DG or OPT-821. The initial 8 patients will receive the same QS-DG or OPT-821 vaccine dose in all of their vaccines. This dose will be 50 mcg for the first patient, 75 mcg for the second patient and 100 mcg for the third through eighth patients. In all subsequent patients the 1st, 4th and 5th vaccinations will include 150 mcg of OPT-821. The 2nd and 3rd vaccinations will contain 100 mcg of OPT-821 and the 6th vaccination will contain 200 mcg of OPT-821. | Biological | 1 |
Primary outcome
Toxicity
Time frame: 2 years
Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Chapman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KLH conjugates with GD2L and GD3L in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.