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An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma


Phase 1
N/A
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma


OBJECTIVES:

- Determine the safety and adverse event profile of anti-cytotoxic
T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376,
gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients
with resected stage III or IV melanoma.

- Determine if this regimen causes antigen-specific T-cell activation in these patients.

- Determine the clearance profile of this regimen in these patients.

- Assess the development of host immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4
monoclonal antibody (MDX-CTLA4).

Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in
Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4,
5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum
tolerated dose is determined.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed completely resected stage III or IV melanoma

- Mucosal or ocular subtypes allowed

- HLA-A2 positive

- Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or
MART-1

- Failed (or ineligible for or refusal of) interferon alfa

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 12 months

Hematopoietic:

- WBC at least 2,500/mm^3

- Absolute neutrophil count at least 1,500/mm^3

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

- Hemoglobin at least 10 g/dL

- Hematocrit at least 30%

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- AST no greater than 1.25 times ULN

- Hepatitis B surface antigen negative

- Hepatitis C antibody nonreactive

Renal:

- Creatinine less than 1.25 times ULN

Immunologic:

- Antinuclear antibody (ANA) negative OR

- If ANA positive, must be:

- Antithyroglobulin antibody negative

- Rheumatoid factor negative

- Anti-LKM antibody negative

- Anti-phospholipid antibody negative

- Anti-islet cell antibody negative

- Anti-neutrophil cytoplasmic antibody negative

- HIV negative

- No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease)

- No active infection

- No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide
ISA-51

Other:

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the
cervix

- No underlying medical condition that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

- No prior tyrosinase, gp100, or MART-1 peptide

- No prior antitumor vaccination

- No prior interleukin-2

- At least 4 weeks since prior immunotherapy for melanoma

Chemotherapy:

- At least 4 weeks since prior chemotherapy for melanoma

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy for melanoma

- At least 4 weeks since prior corticosteroids

- No concurrent systemic or topical corticosteroids

Radiotherapy:

- At least 4 weeks since prior radiotherapy for melanoma

Surgery:

- See Disease Characteristics

Other:

- No prior cytotoxic therapy

- At least 4 weeks since any other prior therapy for melanoma

- Concurrent analgesics allowed if on stable dose for at least 2 weeks before study

Type of Study:

Interventional

Study Design:

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:

CDR0000068934 (10M-00-4)

NCT ID:

NCT00025181

Start Date:

October 2001

Completion Date:

June 2005

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 III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

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