Status:
COMPLETED
A Trial of JX-594 in Refractory Colorectal Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to: * determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion. * determine the safety...
Detailed Description
This is a Phase 1b, open-label, dose-escalation trial in patients with advanced colorectal carcinoma (CRC) that have failed both oxaliplatin based and irinotecan based prior chemotherapy regimens for ...
Eligibility Criteria
Inclusion
- Histologically-confirmed, advanced/metastatic colorectal carcinoma
- Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (tumor progression on or within 3 months of treatment completion)
- Erbitux therapy resistant: Ras mutant tumor status, and/or failed Erbitux therapy (tumor progression on or within 3 months of treatment completion or Erbitux treatment not indicated due to lack of epidermal growth factor (EGFR) expression)
- At least one measurable tumor mass by PET-CT/CT/MRI (lesion that can accurately be measured in at least one dimension with longest diameter \> 1 cm)
- Expected survival for approximately 12 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 (transfusion allowed)
- Platelet count ≥ 100,000 plts/mm3
- Total bilirubin ≤ 1.5 ULN
- AST, ALT ≤2.5 ULN (if liver metastases(+): AST,ALT ≤5.0 x ULN)
- Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - 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.
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
- 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 (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, including (for example) coronary artery disease requiring increased doses of anti-anginal mediation and/or coronary angioplasty (including stent placement) within the preceding 24 months
- Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery 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 \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\] Low dose aspirin (approximately 81 mg) allowed.
- 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 \< 12 months 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)Patients with household contacts meeting any of the above criteria will be excluded unless alternate living arrangements can be made during the patient's dosing period and for at least 7 days following the last dose of study medication.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01469611
Start Date
July 1 2010
End Date
January 1 2015
Last Update
February 17 2017
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea