Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Completed · Phase 2
Conditions studied: Recurrent Melanoma, Stage IV Melanoma
In brief
Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells
Key facts
- Study ID
- NCT00005949
- Run by
- National Cancer Institute (NCI)
- People needed
- 50
- Starts
- 2001-03-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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