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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

  1. Safety if less than 33% of patients experience a dose-limiting at day 22

Secondary outcomes (1)
  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.

  1. First posted11 Jul 2005 (estimated)
  2. Study start4 Nov 2004
  3. Primary completion28 Jul 2006
  4. Study completion28 Jul 2006

Resources

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)
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

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.

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