Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089219
• Other study ID #: 10464
• Secondary ID: UVACC-MEL-41UVAC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 4, 2004
• Last updated: November 18, 2014
• Start date: July 2003

Study information

• Verified date: November 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Description:

OBJECTIVES:

• Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.

• Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

• Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIIB, IIIC, or IV melanoma

• HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive

• Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

• 18 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

• Liver function tests = 2.5 times upper limit of normal (ULN)

Renal

• Creatinine = 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• Prior diagnosis of other cancer allowed

• Not pregnant or nursing

• Weight = 110 pounds

• No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior growth factors

• More than 4 weeks since prior allergy shots

• More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine

• No prior vaccination with any of the peptides used in this study

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 1 month since prior investigational drugs or therapies

• No other concurrent investigational drugs or therapies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Biological:
• IFA
vaccine adjuvant
• 6MHP
melanoma helper peptides
• GM-CSF
vaccine adjuvant

Locations

Country	Name	City	State
United States	University of Virginia Cancer Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Slingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK. Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Dose-limiting toxicity	Toxicities measured by CTCAE.	During study period	Yes
Primary	Immunogenicity	Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.	day 22	No
Secondary	Immune response in the blood	Immune response measured in the blood, by proliferation assay, over time during the study.	day 50	No
Secondary	DTH response	Delayed-type hypersensitivity response to tumor peptides	by day 85	No
Secondary	Clinical outcome	Clinical tumor response	during the study	No