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A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma

Phase 3
18 Years
Not Enrolling
Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

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Trial Information

A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma


I. To identify whether the addition of the peptide vaccine to high dose IL-2 (aldesleukin)
can result in a clinical response rate which may be superior to that found in similar
patients treated with high dose IL-2 alone.


I. To evaluate the toxicity profile of patients treated on this trial, according to the
regimen received.

II. To compare the disease free/progression free survival of patients treated on both arms
of the study.

III. To determine the immunologic response experienced by patients who have received the
peptide vaccination, as measured by changes in T-cell precursors from before to after

IV. To evaluate the quality of life of patients before and after high-dose IL-2.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease site (cutaneous or subcutaneous only vs any other site with or without subcutaneous
disease). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses.

ARM II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day
1. Patients also receive IL-2 as in arm I beginning on day 2.

In both arms, treatment repeats every 3 weeks for 2 courses. Patients with stable or
responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional
courses. Patients with complete response may receive a maximum of 2 additional courses.

Quality of life is assessed before and after the first course of IL-2.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 93-185 patients (46-93 per treatment arm) will be accrued for
this study within 2 years.

Inclusion Criteria:

- Any patient with measurable metastatic (stage IV or locally advanced stage III)
cutaneous melanoma and an expected survival of greater than three months will be

- Serum creatinine of 1.6 mg/dl or less

- Total bilirubin 1.6 mg/dl or less

- WBC 3000/mm^3 or greater

- Platelet count 90,000 mm^3 or greater

- Serum AST/ALT less then three times normal

- ECOG performance status of 0 or 1

- Patients of both genders must be willing to practice effective birth control during
this trial

- Pathologic confirmation of cutaneous melanoma; patients may enter the study with a
pathologic diagnosis of cutaneous melanoma from any institution; all slides will be
reviewed at National Institutes of Health (NIH) (department of Anatomic Pathology)
and if the diagnosis is not confirmed, the patient will be excluded from the study

- Tissue type human leukocyte antigen (HLA) A0201

Exclusion Criteria:

- Patients who have types of melanoma other than cutaneous, i.e. ocular or mucosal

- Patients who are undergoing or have undergone in the past 4 weeks any other form of
therapy except surgery for their cancer, including radiation therapy to any site

- Patients who have active systemic infections, coagulation disorders, autoimmune
disease or history of other major medical illnesses such as insulin dependent
diabetes mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias,
obstructive or restrictive pulmonary diseases and inflammatory bowel disorders

- Patients who have significant psychiatric disease which in the opinion of the
principal investigator would prevent adequate informed consent or render
immunotherapy unsafe or contraindicated

- Patients who require steroid therapy or steroid-containing compounds, or have used
systemic steroids in the past 4 weeks, or have used topical or inhalational steroids
in the past 2 weeks

- Patients who are pregnant

- Patients who are known to be positive for viral hepatitis B or C (HBsAg or Anti HCV)
or HIV (HIV antibody)

- Patients who have any form of primary or secondary immunodeficiency

- Patients who have received previous high dose IL-2 (> 600,000 IU/kg)

- Patients who have received previous gp100 vaccines

- Patients who have an abnormal stress cardiac test (stress thallium, stress MUGA,
dobutamine echocardiogram or other stress test that will rule out cardiac ischemia)

- Patients who have abnormal pulmonary function tests (FEV1 < 65% or FVC < 65% of

- Patients who have brain metastasis or history of brain metastasis

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease free for 5 years

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Best response rate (partial response [PR] + complete response [CR])

Outcome Description:

The Chi-squared test will be used for evaluating differences in response rates. Stratified analyses, such as Thomas's test for combining Fisher's exact tests could be used as part of the stratified analysis as well.

Outcome Time Frame:

Up to 12 years

Safety Issue:


Principal Investigator

Douglas Schwartzentruber

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Health Goshen Center for Cancer Care


United States: Food and Drug Administration

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Melanoma



Indiana University Health Goshen Center For Cancer Care Goshen, Indiana  46526