Vaccine Therapy in Treating Patients With Metastatic Melanoma

Stopped early · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Melanoma

In brief

Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Key facts

Study ID

NCT00087373

Run by

National Cancer Institute (NCI)

People needed

28

Starts

2004-06-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed melanoma
• Stage IV disease
• Measurable disease
• At least 1 cutaneous or lymph node mass ≥ 1 cm AND amenable to biopsy and percutaneous injection AND can be accurately measured with standard calipers
• Must be tested for expression of HLA-A2 prior to study
• Must have 1 of the following criteria:
• Circulating melanoma-specific CD8-positive T cells against ≥ 1 defined antigen (Melan-A, gp100 antigen, tyrosinase, MAGE-A10, Trp-2, or NA17) as measured by tetramer or ELISpot directly ex-vivo or after a 10 day in vitro expansion
• Detectable intratumoral T cells measured in the index lesion that is to be injected with rF-TRICOMTM by immunohistochemistry (IHC) for CD4, CD8 or another T cell marker, or by real time RT-PCR for CD8a, CD4, or other T cell transcripts
• No untreated or edematous brain metastases or leptomeningeal disease
• Treated CNS disease allowed provided patient remains stable off corticosteroid therapy
• Performance status - Karnofsky 70-100%
• More than 12 weeks
• WBC ≥ 3,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No uncontrolled bleeding disorder that would increase the risk of bleeding from the injected lesion
• No active thrombotic thrombocytopenic purpura within the past 2 years
• PT/PTT ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN
• Bilirubin ≤ 1.5 times ULN
• No chronic hepatitis B or C
• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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