Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells
NCT00087373CI-TRIAL-00014811terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant fowlpox-TRICOM vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (recombinant fowlpox-TRICOM vaccine)
- description
- Patients receive fowlpox-TRICOM intratumorally on day 1 of weeks 1, 4, and 7 (maximum of 3 injections for a single lesion) (course 1). After 3 injections (course 1), patients with stable or responding disease receive additional injections into new lesions following the same schedule as above. Treatment repeats every 9 weeks for a maximum total of 9 injections (3 injections total into a maximum of 3 different tumors) (total of 3 courses) in the absence of disease progression or unacceptable toxicity
- interventionNames
- Biological: recombinant fowlpox-TRICOM vaccine
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Local response defined as complete response (CR), a partial response (PR) stable disease (SD), or progressive disease (PD) in the injected lesion according to RECIST criteria
- timeFrame
- Up to 15 years
- measure
- Overall clinical response (CR or PR) as measured by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.