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Recurrent MelanomaPhase 2NCT00087373

Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Phase 2 study testing recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 is studying how well vaccine therapy works in treating patients with metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Jun 2004to Feb 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 58Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
recombinant fowlpox-TRICOM vaccine, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant fowlpox-TRICOM vaccineBiological

    Also called rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)

    Given intratumorally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00087373
Study groupRoleWhat they receive
Treatment (recombinant fowlpox-TRICOM vaccine)ExperimentalPatients 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
Receives: Biological: recombinant fowlpox-TRICOM vaccine; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 15 years

  2. Overall clinical response (CR or PR) as measured by RECIST criteria

    Measured: Up to 15 years

Secondary outcomes (3)

  1. Change in mRNA expression of B7-1, LFA-3, and/or ICAM-1in the tumor microenvironment

    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.

    Measured: Baseline and week 10

  2. Changes in tumor associated T cells

    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.

    Measured: Baseline and week 10

  3. Time to tumor progression

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

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087373
Sponsor's protocol ID
NCI-2012-02615
Other IDs
NCI-2012-02615, CDR0000374979, UCCRC-12759A, NCI-6038, 12759A, 6038, P30CA014599
Status last verified
Dec 2012
First submitted
8 Jul 2004
Last updated
9 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 58 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: Up to 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.

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