NCT00003568

Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

Official Title:

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

Summary

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.

Eligibility

DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1 OR
* Karnofsky 80-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* 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

Pulmonary:

* FEV_1 greater than 2.0 liters or at least 75% of predicted
* No chronic obstructive pulmonary disease

Other:

* 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior interleukin-2
* At least 4 weeks since prior vaccine therapy or other cytokine therapy

Chemotherapy:

* One prior chemotherapy regimen allowed
* At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered

Endocrine therapy:

* No concurrent steroids

Radiotherapy:

* 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 recovered

Surgery:

* See Disease Characteristics
* Recovered from prior major surgery
* No prior organ allografts

Other:

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

Disease(s) and\or Condition(s)

Melanoma (Skin)

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: aldesleukin
    • Description:
    • Arm Group Labels:
    • Type: BIOLOGICAL
    • Name: gp100 antigen
    • Description:
    • Arm Group Labels:
    • Type: BIOLOGICAL
    • Name: incomplete Freund's adjuvant
    • Description:
    • Arm Group Labels:
Sponsor
  • University of Illinois at Chicago