Suspended

Vaccine Therapy in Treating Patients With Metastatic Melanoma

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What is being tested

recombinant fowlpox-TRICOM vaccine

+ laboratory biomarker analysis
Biological
Other
Who is being recruted

Recurrent Melanoma

+ Stage IV Melanoma
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: June 9, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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. 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 agent. III. Determine systemic clinical response in patients treated with this agent. SECONDARY OBJECTIVES: 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 months.

Official TitlePhase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells 
Principal SponsorNational Cancer Institute (NCI)
Last updated: June 9, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
28 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Recurrent Melanoma
Stage IV Melanoma
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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
Study Objectives
Primary Objectives

Secondary Objectives

Changes in laboratory correlates pre- versus post- treatment will be analyzed using a paired t-test. The association between changes in these measurements and tumor response will be assessed by comparing the changes in responders and non-responders using a Wilcoxon rank-sum test.

Changes in laboratory correlates pre- versus post- treatment will be analyzed using a paired t-test. The association between changes in these measurements and tumor response will be assessed by comparing the changes in responders and non-responders using a Wilcoxon rank-sum test.

Time to tumor progression will be analyzed by the Kaplan-Meier method.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of ChicagoChicago, United StatesSee the location

SuspendedOne Study Center