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A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck

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Trial Information

A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors


Inclusion Criteria:



- Histologically-confirmed, advanced/metastatic solid tumor refractory to standard
therapy or the patient has refused or does not tolerate the standard therapy; tumors
may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and
squamous cell carcinoma of the head and neck

- At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be
measured in at least one dimension with longest diameter > 1 cm)

- At least one tumor mass amenable to biopsy and/or FNA

- Expected survival for approximately 16 weeks or longer

- Karnofsky Performance Score (KPS) ≥ 70

- Age ≥18 years

- WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3

- ANC ≥ 1,500 cells/mm3

- Hemoglobin ≥ 10 g/dL

- Platelet count ≥ 100,000 plts/mm3

- Total bilirubin ≤ 1.5 x ULN

- AST, ALT ≤ 2.5 x ULN

- Serum chemistries within normal limits (WNL) or Grade 1 - If patients are diabetic or
have a screening random glucose > 160 mg/dL, a fasting glucose must be done and
patients must be WNL or Grade 1 in order to be eligible for the study.

- Acceptable coagulation status: INR ≤ (ULN + 10%)

- CD4 count ≥ 500/mm3

Exclusion Criteria:

- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
medication (e.g. systemic corticosteroids)

- Known myeloproliferative disorders requiring systemic therapy

- History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring
systemic therapy

- Tumor(s) invading a major vascular structure (e.g. carotid artery)

- Tumor(s) in location that would potentially result in significant clinical adverse
effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the
upper airway or affecting biliary tract drainage, etc.)

- Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or
pleural effusions

- Severe or unstable cardiac disease

- Current, known CNS malignancy (history of completely resected or irradiated brain
metastases allowed)

- Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case
of mitomycin C or nitrosoureas)

- Use of anti-viral, anti-platelet, or anti-coagulation medication [Patients who
discontinue such medications within 7 days prior to first treatment may be eligible
for this study.]

- Pulse oximetry O2 saturation <90% at rest

- Experienced a severe systemic reaction or side-effect as a result of a previous
smallpox vaccination

Household contact exclusions:

- Women who are pregnant or nursing an infant

- Children < 5 years old

- History of exfoliative skin condition (e.g. eczema) that at some stage has required
systemic therapy

- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
medication (e.g. systemic corticosteroids)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

David Kirn, MD

Investigator Role:

Study Director

Investigator Affiliation:

Jennerex Inc.

Authority:

United States: Food and Drug Administration

Study ID:

JX594-IV-011

NCT ID:

NCT00625456

Start Date:

June 2008

Completion Date:

August 2013

Related Keywords:

  • Melanoma
  • Lung Cancer
  • Renal Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • phase I
  • advanced metastatic solid tumors
  • oncolytic virus
  • vaccinia virus
  • melanoma
  • lung cancer
  • renal cell carcinoma
  • squamous cell carcinoma of the head and neck
  • Pexa-Vec
  • Carcinoma
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Lung Neoplasms
  • Melanoma
  • Vaccinia
  • Head and Neck Neoplasms

Name

Location

Cancer Centers of the CarolinasGreenville, South Carolina  29605
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Billings ClinicBillings, Montana  59107-7000