Status:
COMPLETED
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
Lead Sponsor:
Jennerex Biotherapeutics
Conditions:
Melanoma
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00625456
Start Date
June 1 2008
End Date
June 1 2014
Last Update
December 3 2015
Active Locations (4)
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1
Billings Clinic
Billings, Montana, United States, 59101
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States
3
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
4
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6