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A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma


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

Thank you

Trial Information

A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma


OBJECTIVES:

- Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV
melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with
Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are stratified according to disease stage
(cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are
randomized to 1 of 3 treatment arms.

- Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217
(210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose
interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1,
3, 5, 7, 11, 15, 19, 27, and 53.

- Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC,
and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.

- Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose
IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27,
and 53.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular
or mucosal melanoma

- Resected or rendered disease-free

- HLA-A2.1-positive by standard cytotoxicity assay

- Tumor tissue must be available for analysis of gp100 staining and tyrosinase and
MART-1 expression by immunohistochemistry

- Must be positive for at least 1 antigen

- Failed, ineligible for, or refused prior interferon alfa

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

- No bleeding disorder

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT/SGPT no greater than 2.5 times normal

- No coagulation disorder

- Hepatitis surface antigen B negative

- Hepatitis C negative

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No major cardiovascular illness

Pulmonary:

- No major respiratory illness

Immunologic:

- No prior uveitis

- No prior autoimmune inflammatory eye disease

- No immune hemolytic anemia

- No other active autoimmune disease

Other:

- HIV negative

- No major gastrointestinal illness

- No other malignancy within the past 5 years except squamous cell skin cancer or
carcinoma in situ of the cervix curatively treated at least 30 days ago

- No major systemic infection (e.g., pneumonia or sepsis)

- No other major medical illness

- No prior allergic reaction to Montanide ISA-51 or alum adjuvant

- No requirement for steroid therapy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L)
peptides

Chemotherapy:

- At least 1 month since prior adjuvant chemotherapy for this disease

- No concurrent adjuvant chemotherapy

Endocrine therapy:

- No concurrent steroids

Radiotherapy:

- At least 1 month since prior radiotherapy for this disease

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 1 month since other prior therapy, including adjuvant therapy, for this
disease

- No other concurrent therapy, including adjuvant therapy

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:

CDR0000069220 (10M-01-1)

NCT ID:

NCT00031733

Start Date:

February 2002

Completion Date:

November 2007

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • iris melanoma
  • ciliary body and choroid melanoma, small size
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804