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Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

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Trial Information

Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells


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 agent. III. Determine
systemic clinical response in patients treated with this agent.


I. Determine the increase in transgene expression of B7-1, leukocyte function-associated
antigen-3 (LFA-3), and intercellular adhesion molecule-1 (ICAM-1) in patients treated with
this agent.

II. Determine the effects of this agent on CD8-positive antitumor T-cell frequency as
measured by tetramer and ELISpot in patients who are HLA-A2 positive.

III. Correlate transgene expression of B7-1, LFA-3, and ICAM-1 by tumor cells with changes
in function or number of melanoma antigen-specific CD8-positive T lymphocytes in patients
treated with this agent.

OUTLINE: This is a multicenter study.

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.

Patients are followed every 3 months until disease progression and then approximately every
6 months for 5-15 years.

PROJECTED ACCRUAL: A total of 14-28 patients will be accrued for this study within 14-28

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

Up to 15 years

Safety Issue:


Principal Investigator

Thomas Gajewski

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470