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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennerex Biotherapeutics
• Collaborator: Samsung Medical Center
• Treatments: Molgramostim; Sargramostim

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)