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A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma


OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with
Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in
HLA-A2 positive patients with stage III or IV melanoma.

OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy
(immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2
treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides
emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2,
4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients
receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2,
4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks,
then every 3 months for 2 years after resection, then every 6 months for 3 years, and then
yearly if without evidence of disease.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular
melanoma that can be completely resected or rendered free of disease but is at high risk
of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused
interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of
gp100/tyrosinase expression Detectable expression of one or the other antigen not required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic:
Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine
clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No
major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal
illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No
coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative
Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye
disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second
malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month
since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy,
including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine
therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior
radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066310 (10M-97-3)

NCT ID:

NCT00003339

Start Date:

November 1998

Completion Date:

September 2004

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • recurrent intraocular melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Beckman Research Institute, City of HopeLos Angeles, California  91010