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Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma


Phase 1
12 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Craig L. Slingluff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000430925

NCT ID:

NCT00118313

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908