MelanomaMEL38NCT00912574
Evaluation of the Effects of Local Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes: MEL38
A study testing GM-CSF-in-adjuvant, Montanide ISA-51 and GM-CSF and Montanide ISA-51 in people with Melanoma, run by University of Virginia at 1 site in United States.
Trial summary
Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant. Design: Open-label, single dose study in two stages. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma
- What is being tested?
- GM-CSF-in-adjuvant, Montanide ISA-51 and GM-CSF and Montanide ISA-51
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
- Patients who have any evidence of metastasis will not be eligible.
- All patients must have:
- Karnofsky performance of 80% or higher
- ECOG performance status of 0 or 1
- Ability and willingness to give informed consent
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- Laboratory parameters as follows:
- ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)
- Platelets: 100-500 x 103/uL
- Hgb: 90% LLN to 120% ULN
- Hepatic:
- AST, ALT, Bilirubin, and Alk phos within normal limits,
- LDH up to 1.2 x ULN
- Renal:
- Creatinine up to 1.5 x ULN
- Age 18-85 years at the time of study entry.
Who cannot join
- Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 weeks.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents),
- Allergy desensitization injections,
- Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable.
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- Any growth factors, Interleukin-2 or other interleukins.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the injection.
- Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
- Patients with serious symptomatic active pulmonary disease, with pleural effusions, or with a history of pulmonary edema.
- Patients who have systemic autoimmune disease with visceral involvement.
- Patients with clinically apparent skin infection or other clinically evident inflammation involving the skin adjacent to the melanoma biopsy scar.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant.
Design: Open-label, single dose study in two stages.
Read the detailed description
Regimen: Each injection will be administered to patients with clinical stage I or II melanoma, who have had complete excision of a primary melanoma, but prior to wide excision with or without sentinel node biopsy as definitive surgical therapy.
In Stage 1: Patients will be injected with a 1 ml emulsion containing GM-CSF in saline plus Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In Stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar:
- 1 ml saline
- GM-CSF in 1 ml saline
- an emulsion of Montanide ISA-51 adjuvant and saline
- an emulsion of GM-CSF in saline plus ml Montanide ISA-51 adjuvant. All vaccines will be administered intradermally. After the injection, each patient will undergo wide excision of the melanoma site, with or without sentinel node biopsy, as clinically indicated.
- Conditions
- Melanoma
- Being tested
- GM-CSF-in-adjuvant, Montanide ISA-51, GM-CSF and Montanide ISA-51, Saline
- Keywords
- Melanoma, adjuvant, dendritic cells, vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSF-in-adjuvantDrug
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
- 1 ml saline
- specified dose of GM-CSF in 1 ml saline
- an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
- an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Montanide ISA-51Drug
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
- 1 ml saline
- specified dose of GM-CSF in 1 ml saline
- an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
- an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
GM-CSF and Montanide ISA-51Biological
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
- 1 ml saline
- specified dose of GM-CSF in 1 ml saline
- an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
- an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
SalineDrug
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
- 1 ml saline
- specified dose of GM-CSF in 1 ml saline
- an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
- an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | first of 4 arms: injection: 1 ml saline Receives: Drug: Saline |
| GM-CSF | Active comparator | Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline Receives: Drug: GM-CSF-in-adjuvant |
| 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline | Active comparator | Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline Receives: Drug: Montanide ISA-51 |
| GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant | Active comparator | Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant Receives: Biological: GM-CSF and Montanide ISA-51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Proportion of the sentinel node occupied by dendritic cells (total and mature)
Secondary outcomes (1)
Time to maximal dendritic cell infiltration into the dermis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2004
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Craig L Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912574
- Sponsor's protocol ID
- 8380
- Acronym
- MEL38
- Status last verified
- Jun 2009
- First submitted
- 1 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
- ClinicalTrials.gov ID
- NCT00912574
- Acronym / sponsor ID
- MEL38 / 8380
- Conditions
- Melanoma
- Keywords
- Melanoma, adjuvant, dendritic cells, vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jul 2008 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant.
Design: Open-label, single dose study in two stages.
Detailed description
Regimen: Each injection will be administered to patients with clinical stage I or II melanoma, who have had complete excision of a primary melanoma, but prior to wide excision with or without sentinel node biopsy as definitive surgical therapy.
In Stage 1: Patients will be injected with a 1 ml emulsion containing GM-CSF in saline plus Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In Stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar:
- 1 ml saline
- GM-CSF in 1 ml saline
- an emulsion of Montanide ISA-51 adjuvant and saline
- an emulsion of GM-CSF in saline plus ml Montanide ISA-51 adjuvant. All vaccines will be administered intradermally. After the injection, each patient will undergo wide excision of the melanoma site, with or without sentinel node biopsy, as clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Drug: Salinefirst of 4 arms: injection: 1 ml saline |
| GM-CSF | Active comparator | Drug: GM-CSF-in-adjuvantSecond of 4 arms: injection: specified dose of GM-CSF in 1 ml saline |
| 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline | Active comparator | Drug: Montanide ISA-51Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline |
| GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant | Active comparator | Biological: GM-CSF and Montanide ISA-51Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
- Patients who have any evidence of metastasis will not be eligible.
- All patients must have:
- Laboratory parameters as follows:
- Age 18-85 years at the time of study entry.
Key exclusion criteria (13 listed)
- Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 weeks.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the injection.
- Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
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 |
|---|---|---|
| GM-CSF-in-adjuvantFor each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar. In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant | Drug | GM-CSF |
| Montanide ISA-51For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar. In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant | Drug | 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline |
| GM-CSF and Montanide ISA-51For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar. In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant | Biological | GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant |
| SalineFor each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar. In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant | Drug | Saline |
Primary outcome
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Proportion of the sentinel node occupied by dendritic cells (total and mature)
1 secondary outcome
Time to maximal dendritic cell infiltration into the dermis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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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.
Craig L Slingluff, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GM-CSF-in-adjuvant, Montanide ISA-51 and GM-CSF and Montanide ISA-51 in people with Melanoma, run by University of Virginia 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 16 inclusion and 13 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 3 Jun 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant. The study lists 2 primary outcomes in all. 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 3 Jun 2009.