Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 to 79 NCI UVACC-HIC-6346 UVA-HIC-6346, NCI-H98-0010, NCT00003224

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.

Entry 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

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
 

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 

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

University of Virginia Cancer Center

Craig Slingluff, MD, Protocol chair		Ph: 434-243-2611; 800-223-9173 Email: cls8h@virginia.edu

Registry Information
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
Trial Start Date		1996-02-20
Registered in ClinicalTrials.gov		NCT00003224
Date Submitted to PDQ		1998-02-19
Information Last Verified		2000-05-01