Status:
TERMINATED
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 i...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with metastatic melanoma. II. Determine the local response rate in patients treated with this ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- HIV negative
- No prior significant allergic reaction or hypersensitivity to eggs or egg products
- No disease that limits the function of the spleen (e.g., sickle cell disease)
- No uncontrolled active or chronic infection
- No active autoimmune disorders or disease
- No immunosuppression, defined as concurrent or possible requirement for systemic corticosteroids
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- Able to avoid direct contact of the immunization site with the following individuals:
- Children \< 3 years of age
- Immunocompromised individuals (including those on systemic corticosteroids)
- Pregnant women
- Individuals with extensive skin disease
- No active seizure disorder
- No skin disease and/or open unhealing wounds
- No psychiatric illness or social situation that would preclude study compliance
- No other significant medical illness that would significantly increase the risk associated with immunotherapy
- No other active malignancy requiring concurrent therapy except squamous cell or basal cell skin cancer or undetectable hormone-responsive prostate cancer (as measured by normal prostate-specific antigen)
- No other concurrent uncontrolled illness that would preclude study participation
- No prior fowlpox virus-based therapy
- No prior B7-1, intercellular adhesion molecule-1 (ICAM-1), or leukocyte function-associated antigen-3 (LFA-3)
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- See Disease Characteristics
- Concurrent adjuvant hormonal therapy for early-stage or high-risk breast cancer allowed
- No concurrent corticosteroids
- More than 2 weeks since prior radiotherapy and recovered
- More than 2 weeks since prior surgery and recovered
- No prior splenectomy
- No concurrent therapeutic anticoagulation therapy that would increase the risk of bleeding from injected lesion
- No other concurrent immunosuppressive drugs
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00087373
Start Date
June 1 2004
Last Update
June 9 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637