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

Jennerex Biotherapeutics

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Colorectal

Treatments

Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01380600

JX594-IV-CRC014

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)