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Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides


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

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Trial Information

Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides


OBJECTIVES:

- Compare immune response in patients with stage IIB-IV melanoma treated with vaccination
comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without
sargramostim (GM-CSF).

- Compare immune response in patients treated with these vaccinations administered at 1
vs 2 sites.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment
arms.

- Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and
Montanide ISA-51 at 1 injection site.

- Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides
and Montanide ISA-51 at 2 injection sites.

- Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides,
Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.

- Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides,
Montanide ISA-51, and GM-CSF at 2 injection sites.

In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster
vaccinations at weeks 12, 26, 39, and 52.

PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of melanoma

- Stage IIB, IIC, III, or IV disease

- Must express HLA-A1, -A2, or -A3

- No ocular melanoma

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

- Not pregnant or nursing

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy

- More than 4 weeks since prior growth factors

- More than 4 weeks since prior allergy shots

- No prior vaccine therapy for melanoma or any other cancer with any of the peptides
used in this study

- More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma
vaccine allowed only for patients with disease progression during or after
administration of the vaccine

Chemotherapy

- More than 4 weeks since prior chemotherapy

Endocrine therapy

- More than 4 weeks since prior steroids

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, 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:

CDR0000378169

NCT ID:

NCT00089193

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
MD Anderson Cancer Center at University of TexasHouston, Texas  77030-4009