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Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma


Phase 1
18 Years
79 Years
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma


OBJECTIVES: I. Compare the safety and 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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed unresectable metastatic melanoma (AJCC
stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB
and above) No multiple visceral metastases greater than 3 cm in diameter Solitary brain
metastases allowed if less than 2 cm in diameter and successfully treated with surgical
excision or gamma knife radiation therapy HLA-A2 positive

PATIENT CHARACTERISTICS: 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 Other: No known or suspected allergies to any component of the
treatment vaccine Not pregnant Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior interferons At
least 3 months since prior growth factors No prior melanoma vaccinations No concurrent
interferons No concurrent growth factors Chemotherapy: At least 3 months since prior
chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 months since prior
agents with putative immunomodulating activity (except nonsteroidal antiinflammatory
drugs) At least 3 months since prior corticosteroids No concurrent agents with putative
immunomodulating activity (except nonsteroidal antiinflammatory drugs) No concurrent
corticosteroids Radiotherapy: Prior radiotherapy allowed See Disease Characteristics No
concurrent radiotherapy Surgery: Prior surgery allowed See Disease Characteristics Other:
At least 3 months since prior allergy desensitization injections At least 3 months since
other prior investigational drugs or therapy At least 14 days since acute treatment for
serious infection No concurrent allergy desensitization injections No concurrent
investigational drugs or therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Craig L. Slingluff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000066086

NCT ID:

NCT00003224

Start Date:

February 1996

Completion Date:

Related Keywords:

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

Name

Location

Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908