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Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma


I. Determine clinical response rates in patients with advanced melanoma treated with
gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.

II. Assess response duration and progression-free intervals in these patients receiving this


Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on
day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence
of unacceptable toxicity or disease progression. Patients with a complete response (CR)
receive 3 additional courses after achieving CR.

Patients are followed every 9 weeks for 3 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5

Inclusion Criteria:

- Histologically or cytologically confirmed cutaneous melanoma with clinical evidence
of distant, metastatic, unresectable regional lymphatic, or extensive in-transit
recurrent disease

- HLA-A2*0201 positive by genotyping

- Measurable disease as defined by the following:

- At least 1 lesion accurately measured in at least 1 dimension

- At least 20 mm by conventional techniques

- At least 10 mm by spiral CT scan

- Lesions considered intrinsically nonmeasurable include:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Lesions situated in a previously irradiated area

- No ocular or mucosal melanoma

- No prior or concurrent liver or brain metastases

- Performance status - ECOG 0-1

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

- Hemoglobin at least 10 g/dL

- LDH normal

- Bilirubin normal

- AST no greater than 2.5 times upper limit of normal

- Creatinine normal

- No congestive heart failure, angina, or symptomatic cardiac arrhythmia

- No myocardial infarction within the past 6 months

- No severe chronic pulmonary disease

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No primary or secondary immunodeficiency or autoimmune disease

- No currently active second malignancy (e.g., patient has completed therapy and is
considered unlikely to have recurrence within 1 year) other than nonmelanoma skin

- At least 4 weeks since prior immunotherapy

- No prior interleukin-2

- No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine

- No other concurrent cytokines or growth factors

- At least 4 weeks since prior chemotherapy

- At least 1 month since prior systemic corticosteroids

- No concurrent systemic, inhaled, or topical corticosteroids

- At least 1 month since other prior immunosuppressive medication

- No antihypertensive medications from 1 day prior until 2 days after first course

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate (CR or PR)

Outcome Time Frame:

From the start of treatment until disease progression/recurrence, assessed up to 3 years

Safety Issue:


Principal Investigator

John Roberts

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



Cancer and Leukemia Group B Chicago, Illinois  60606