Safety Study of Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

Launched by JENNEREX BIOTHERAPEUTICS · Jun 22, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically-confirmed, advanced/metastatic colorectal carcinoma
• • Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (if tumor advanced either immediately or within 3 months of the end of treatment)
• • Resistance to Erbitux: patients with Ras mutations, or for whom Erbitux has failed (if tumor advanced either immediately or within 3 months of the end of treatment, or there is no response to Erbitux therapy due to a lack of expression of EGFR (epidermal growth factor))
• • Karnofsky Performance Score (KPS) ≥ 70
• • Age ≥18 years
• • Laboratory Safety: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3,Total bilirubin ≤ 1.5 X ULN, INR ≤ 1.5, AST, ALT ≤ 2.5x ULN (in case of liver metastasis: AST,ALT ≤5.0 x ULN)
• • Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic, a fasting glucose must be done and patients must be \> 160 mg/dL.
• • Patients who, if they are sexually active, are willing and able to refrain from sexual activity for 3 weeks following JX-594 administration. Patients who are willing and able to use a permitted contraceptive for 3 months after the final administration of JX-594.
• 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
• • History of acquiring opportunistic infections.
• • 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
• • Clinically uncontrolled and/or rapidly accumulating ascites, pericardial and/or pleural effusions
• • History of severe or unstable cardiac disease
• • Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
• • Administered 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 \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\] Low dose aspirin (approximately 81 mg) allowed.
• • Pulse oximetry O2 saturation \<90% Pulse oximetry O2 saturation \<90% at rest
• • Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
• • Pregnant or nursing
• * Household contact exclusions:
• • Women who are pregnant or nursing an infant
• • Children \< 5 years old
• • People with skin disease (e.g. eczema, atopic dermatitis, and related diseases
• • Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologic malignancies)