Melanoma (Skin)Phase 1NCT00118313
Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
A Phase 1 study testing incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim in people with Melanoma (Skin), run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2004to 28 Jul 2006
- Phase
- Phase 1
- 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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma
- Stage II-IV disease
- Has undergone surgical resection within the past 12 months
- No clinical or radiological evidence of disease after surgical resection
- Must have ≥ 1 undissected axillary and/or inguinal lymph node basin
- HLA-A1, -A2, or -A3 positive
- Ineligible for OR refused interferon
PATIENT CHARACTERISTICS:
Age
- 12 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Lactic dehydrogenase ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Hepatitis C negative
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
- HIV negative
- No known or suspected allergy to any component of the study vaccines
- No autoimmune disorder with visceral involvement
- No prior active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- The following immunologic conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring non-steroidal anti-inflammatory drugs
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 110 lbs
- No uncontrolled diabetes
- Hemoglobin A1C < 7% (for patients with diabetes)
- No medical contraindication or potential problem that would preclude study compliance
- No known active addiction to alcohol or drugs
- No recent (within the past year) or ongoing illicit IV drug use
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior vaccinations that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago
- Prior multi-epitope melanoma peptide vaccine that resulted in a negative immune response allowed
- More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®)
- More than 4 weeks since prior and no concurrent allergy desensitization injections
- No influenza vaccine for at least 2 weeks before or after study vaccine administration
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas [e.g., carmustine or lomustine])
- No concurrent chemotherapy, including nitrosoureas
Endocrine therapy
- More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids (e.g., prednisone)
- No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, Azmacort®)
- Concurrent topical corticosteroids allowed
Radiotherapy
- More than 4 weeks since prior and no concurrent radiotherapy
- Prior stereotactic radiosurgery allowed provided it was completed within the past 12 months
Surgery
- See Disease Characteristics
- More than 4 weeks since prior surgical resection of metastatic lesion(s)
- No concurrent surgery requiring general anesthesia
Other
- More than 4 weeks since prior and no other concurrent investigational agents
- More than 30 days since prior and no concurrent participation in another clinical study
- No other concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Read the detailed description
OBJECTIVES:
- Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in patients who have undergone surgical resection for stage II-IV melanoma.
- Determine, preliminarily, the immunogenicity of these regimens in these patients.
- Correlate, preliminarily, transdermal administration of these vaccines with the recruitment and maturation of epidermal Langerhans cells in these patients.
- Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and subcutaneously, on the persistence of immune response in these patients.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.
- Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod topically on days 0, 7, and 14.
- Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113, and 134.
- Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 and 5 weeks and then at disease progression.
PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be accrued for this study within approximately 2 years.
- Conditions
- Melanoma (Skin)
- Being tested
- incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine, sargramostim, tetanus toxoid helper peptide, dimethyl sulfoxide
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incomplete Freund's adjuvantBiological
multi-epitope melanoma peptide vaccineBiological
sargramostimBiological
tetanus toxoid helper peptideBiological
dimethyl sulfoxideDrug
imiquimodDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety if less than 33% of patients experience a dose-limiting at day 22
Secondary outcomes (1)
Immune response by Elispot assay at day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study start4 Nov 2004
- Primary completion28 Jul 2006
- Study completion28 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118313
- Sponsor's protocol ID
- 11490
- Other IDs
- UVACC-MEL-45, UVACC-34204
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2005
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma
- ClinicalTrials.gov ID
- NCT00118313
- Acronym / sponsor ID
- 11490
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2004
- Primary completion
- 28 Jul 2006 (actual)
- Study completion
- 28 Jul 2006 (actual)
- First posted
- 11 Jul 2005 (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.
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Detailed description
OBJECTIVES:
- Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in patients who have undergone surgical resection for stage II-IV melanoma.
- Determine, preliminarily, the immunogenicity of these regimens in these patients.
- Correlate, preliminarily, transdermal administration of these vaccines with the recruitment and maturation of epidermal Langerhans cells in these patients.
- Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and subcutaneously, on the persistence of immune response in these patients.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.
- Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod topically on days 0, 7, and 14.
- Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113, and 134.
- Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 and 5 weeks and then at disease progression.
PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be accrued for this study within approximately 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| incomplete Freund's adjuvant | Biological | – |
| multi-epitope melanoma peptide vaccine | Biological | – |
| sargramostim | Biological | – |
| tetanus toxoid helper peptide | Biological | – |
| dimethyl sulfoxide | Drug | – |
| imiquimod | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Safety if less than 33% of patients experience a dose-limiting at day 22
1 secondary outcome
Immune response by Elispot assay at day 22
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 27 Mar 2020.
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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 Phase 1 study testing incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim in people with Melanoma (Skin), run by Craig L Slingluff, Jr 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?
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 27 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety if less than 33% of patients experience a dose-limiting at day 22. 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 27 Mar 2020.