NCT00003568
Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
PHASE2
COMPLETED
NCT00003568
INTERVENTIONAL
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
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.
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
Melanoma (Skin)
- 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:
- University of Illinois at Chicago