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Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma


OBJECTIVES:

- Determine the antitumor immune response in patients with unresectable stage III or IV
melanoma treated with vaccine comprising multiple synthetic melanoma peptides,
sargramostim (GM-CSF), and Montanide ISA-51.

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides,
sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients
undergo removal of the lymph node draining the vaccination site on day 22 to assess immune
response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of melanoma

- Unresectable stage III or IV disease

- Mucosal or ocular disease allowed

- Positive HLA-A1, -A2, or -A3 expression

PATIENT CHARACTERISTICS:

Age

- 12 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 9 g/dL

Hepatic

- Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No New York Heart Association class III or IV heart disease

Other

- Weight ≥ 100 pounds

- Not pregnant or nursing

- No other malignancy within the past 5 years except squamous cell or basal cell skin
cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in
situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior vaccination with any of the peptides used in this protocol

- More than 1 year since prior melanoma vaccine therapy

- More than 4 weeks since prior immunotherapy

- More than 4 weeks since prior growth factors

- More than 4 weeks since prior allergy shots

Chemotherapy

- More than 4 weeks since prior chemotherapy

Endocrine therapy

- More than 4 weeks since prior steroid therapy

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- Prior tumor resection allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, 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:

10049

NCT ID:

NCT00089206

Start Date:

August 2002

Completion Date:

Related Keywords:

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

Name

Location

Cancer Center at the University of VirginiaCharlottesville, Virginia  22908