A Trial of JX-594 in Refractory Colorectal Carcinoma

NCT01469611 | Completed Phase 1

• 1 other identifier: SMC IRB 2009-06-055
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by biweekly IV infusion.

Conditions

Colorectal Carcinoma

Keywords

advanced/metastatic colorectal carcinoma

Outcome Measures

Primary Outcomes (2)

• Determine the maximally-tolerated dose

  18 months

• Determine the maximum-feasible dose

  18months

Study Arms (1)

JX-594

EXPERIMENTAL

Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.

Biological: JX-594

Interventions

JX-594 BIOLOGICAL

Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.

JX-594

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Women who are pregnant or nursing an infant
• Children \< 12 months old

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Young suk park, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 10, 2011
• Study Start: July 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2015
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

KR (1)