Clinical trial NCT00003224: Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official title: Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma (Skin)
Keywords: stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.

Detailed description: OBJECTIVES:

I. Determine the safety of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.

II. Determine the immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed in these patients, then additional patients are randomized to arms III-VI. Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.

Eligibility criteria: Inclusion criteria:

* Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
* Age: 18 to 79
* Performance status: ECOG 0-2
* Life expectancy: Greater than 12 months
* Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL
* Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN
* Renal: Creatinine no greater than 1.5 times ULN

Exclusion criteria:

* patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months
* known or suspected allergies to any component of the treatment vaccine
* unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months.
* receiving acute treatment for seriouis infection within 14 days.
* Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible.
* Any of the following with 3 months:
* agentes with putative immunomodulating activity (except NSAIDs)
* allergy desensitizing injections
* other investigational agents
* interferons
* corticosteroids
* any growth factors
* prior melanoma vaccinations
* pregnancy or the possibility of becoming pregnant on study
* medical contraindication or potential problems in complying with the requirements of the protocol.

Primary outcomes:
measure: Safety: Grade 3 Adverse Events
timeFrame: Up to 24 months after last vaccine
Secondary outcomes:
measure: Immunogenicity of Each Vaccine Regimen
timeFrame: up to 12 months since enrollment
Other outcomes:
measure: Number of Participants With a Proliferative Response to Tetanus Helper Peptide
timeFrame: during vaccination
Locations:
city: Charlottesville
country: United States
facility: Cancer Center, University of Virginia HSC
state: Virginia
Study officials:
affiliation: University of Virginia
name: Craig L. Slingluff, MD
role: STUDY_CHAIR
References:
citation: Slingluff CL Jr, Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, Kittlesen D, Deacon D, Hibbitts S, Grosh WW, Petroni G, Cohen R, Wiernasz C, Patterson JW, Conway BP, Ross WG. Phase I trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant: immunologic and clinical outcomes. Clin Cancer Res. 2001 Oct;7(10):3012-24.