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A Phase I/II Study of Isolated Limb Infusion and Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase I/II Study of Isolated Limb Infusion and Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed diagnosis of melanoma
with advanced, unresectable primary or in transit metastasis

- Patient must have measurable disease defined as lesions that can be accurately
measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with
caliper measurement for superficial lesions or computed tomography (CT) scan for
deeper lesions; additionally, patients must have no evidence of disease beyond the
affected extremity on positron emission tomography (PET)/CT scan

- Patients may have undergone any previous systemic chemotherapy with a treatment free
period of > 4 weeks prior to enrolling on this clinical trial

- Patient must be > 18 years of age.-Patient must have an Eastern Cooperative Oncology
Group (ECOG) performance status =< 2, Karnofsky >= 60%

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3.0 x IULN

- Creatinine within normal institutional limits

- OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels
above institutional normal

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she must inform her treating
physician immediately

- Patient (or legally authorized representative if applicable) must be able to
understand and willing to sign an institutional review board (IRB) approved written
informed consent document

Exclusion Criteria:

- Patients must not have had previous oncolytic viral therapy

- Patient must not be receiving any other investigational agents

- Patient must not have known brain metastases; patients with known brain metastases
must be excluded from this clinical trial because of their poor prognosis and because
they often develop progressive neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events

- Patient must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to melphalan or dactinomycin or other agents
used in the study

- Patient must not have an uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements

- Patient must not be pregnant and/or breastfeeding

- Patient must not be known to be human immunodeficiency virus (HIV)-positive or
otherwise immunocompromised (i.e., patient has undergone organ/bone marrow transplant
on immunosuppression, patient is or has recently undergone treatment with toxic
chemotherapy for another malignancy, etc.) as there is a risk of complications in the
use of adenovirus therapy in these patients

Type of Study:


Study Design:

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

Outcome Measure:

Optimal tolerated dose (OTD) of CRAd 3/5

Outcome Description:

Defined as the dose level at which > 50% of target lesion viral infectivity is achieved and < 2 of 6 patients have dose limiting toxicities.

Outcome Time Frame:

14 days

Safety Issue:


Principal Investigator

Ryan Fields, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

February 2016

Related Keywords:

  • Melanoma
  • Melanoma



Washington University School of Medicine Saint Louis, Missouri  63110