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A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma

Phase 2
16 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma


- Define the antitumor activity of gp100:209-217 (210M), a melanoma peptide derived from
gp100 mixed with Montanide ISA-51, in combination with high-dose interleukin-2 (IL-2)
administered by various schedules in patients with advanced melanoma.

- Examine the effect of the addition of gp100:209-217 (210M) peptide vaccine to high-dose
IL-2 on the toxicity of the treatment in these patients.

- Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100
(parent) protein by ELISA with interferon gamma production or CTL precursor frequencies
in these patients after the initial course of treatment.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG
performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients
are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.)

- Arm I: Patients receive vaccination comprising gp100:209-217 (210M) peptide mixed with
Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Patients also receive
high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours on days 2-6 and 16-20.

- Arm II: Patients receive vaccination as in arm I on days 1, 22, 43, and 64. Patients
also receive high-dose IL-2 as in arm I on days 44-48 and 60-64. Patients who
demonstrate rapid visible disease progression during the initial 4 weeks of therapy
while maintaining good performance status may begin high-dose IL-2 on day 23.

- Arm III (closed to accrual as of 11/30/1998): Patients receive vaccination as in arm I
on day 1 and then high-dose IL-2 as in arm I on day 2. Patients with nonhematologic
toxicity may only receive vaccination on weeks 4, 7, and 10. Other patients may also
receive IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14

Patients in each arm may receive up to a total of 3 courses of treatment.

Patients are followed until death.

PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients
for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study
within 12-18 months.

Inclusion Criteria


- Histologically confirmed clearly progressive metastatic or unresectable melanoma

- Must be HLA-A2.1 positive

- Measurable disease

- No active brain metastases, leptomeningeal disease, or seizure disorder

- More than 4 months since prior definitive therapy (surgery or radiotherapy) for
brain metastases and must not have evidence of disease on brain CT scan or MRI

- No ascites or pleural effusions



- 18 and over

Performance status:

- ECOG 0-1 OR

- Karnofsky 80-100%

Life expectancy:

- Not specified


- WBC at least 3,500/mm^3

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

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 2.0 mg/dL


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min


- No congestive heart failure

- No symptoms of coronary artery disease

- No serious cardiac arrhythmias

- No evidence of prior myocardial infarction on EKG

- Normal cardiac stress test required for all patients over 40 years


- FEV_1 greater than 2.0 liters or at least 75% of predicted

- No chronic obstructive pulmonary disease


- HIV negative

- No significant systemic infection

- No contraindication to use of pressor agents

- No history of major psychiatric illness

- No other major illness that would significantly increase the risk of immunotherapy

- No other active malignancy except surgically cured nonmelanoma skin cancer or
carcinoma in situ or stage I carcinoma of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No prior interleukin-2

- At least 4 weeks since prior vaccine therapy or other cytokine therapy


- One prior chemotherapy regimen allowed

- At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and

Endocrine therapy:

- No concurrent steroids


- See Disease Characteristics

- No prior radiotherapy to areas of measurable disease unless there has been clearly
progressive disease in this site or there is measurable disease outside of areas of
prior radiation

- At least 2 weeks since prior radiotherapy for local control or palliative therapy and


- See Disease Characteristics

- Recovered from prior major surgery

- No prior organ allografts


- No antihypertensive therapy within 24 hours prior to interleukin-2

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David M. Gustin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

December 2005

Related Keywords:

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



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Loyola University Medical Center Maywood, Illinois  60153
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
City of Hope Comprehensive Cancer Center Duarte, California  91010
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur Bronx, New York  10466
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516