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A Phase 1/2a Dose-escalation Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Carcinoma, CRC

Thank you

Trial Information

A Phase 1/2a Dose-escalation Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.


Inclusion Criteria:



- Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with
fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had
contradictions to treatment with these drugs as determined by the investigator

- Failed treatment with irinotecan

- Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab
(Vectibix) or had contradictions to treatment

- Regorafenib-naïve (have not received regorafenib)

- ECOG 0, 1 or 2

- Measurable tumor (≥1 cm longest diameter)

- Acceptable health status as determined by the investigator and blood work (Chemistry,
Complete Blood Count, Coagulation)

Exclusion Criteria:

- Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or
Combination Expansion Arm)

- Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if
assigned to combination arm)

- Significant immunodeficiency due to underlying illness and/or medication

- History of severe exfoliative skin condition requiring systemic therapy within the
past 2 years

- Clinically significant and/or rapidly accumulating ascites, pericardial and/or
pleural effusions

- Severe or unstable cardiac disease

- Viable CNS malignancy associated with clinical symptoms

- Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for
mitomycin c or nitrosoureas)

- Prior participation in any other research protocol involving an investigational
medicinal product within 4 weeks prior to first treatment

- Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or
ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose

- Pregnant or nursing an infant

- Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximally-tolerated dose (MTD) or maximum feasible dose (MFD) of JX-594 administered by 5 IV infusions alone and in combination with irinotecan

Outcome Description:

Any of the following treatment related adverse events: Grade 4 toxicity (except isolated G4 lymphopenia lasting ≤ 7 days), Grade 3 or 4 hypotension, disseminated intravascular coagulation (DIC) or allergic reaction/hypersensitivity, Grade 3 non-hematologic toxicity persisting for > 7 days (except for transaminitis (increase in AST and/or ALT), which may last > 7 days if total bilirubin is normal or Grade 1 or flu-like symptoms that respond to standard treatments), or Grade 3 hematologic toxicity persisting for > 7 days.

Outcome Time Frame:

DLTs evaluated until Week 5/Day36

Safety Issue:

Yes

Principal Investigator

James Burke, MD

Investigator Role:

Study Director

Investigator Affiliation:

Jennerex Biotherapeutics

Authority:

United States: Food and Drug Administration

Study ID:

JX594-CRC019

NCT ID:

NCT01394939

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Colorectal Carcinoma
  • CRC
  • Vaccinia
  • Vaccinia Virus
  • JX-594
  • Jennerex
  • Colorectal Carcinoma
  • Colorectal cancer
  • Colon Cancer
  • Rectal Cancer
  • oncolytic virus
  • viral therapy
  • RAS mutant
  • Erbitux failure
  • Oxaliplatin failure
  • FOLFOX failure
  • FOLFIRI failure
  • Irinotecan failure
  • Pexa-Vec
  • Carcinoma
  • Colorectal Neoplasms
  • Vaccinia

Name

Location

Billings Clinic Cancer CenterBillings, Montana  59107-5100
University of North CarolinaChapel Hill, North Carolina  27599
The Ohio State UniversityColumbus, Ohio  43210
Mayo ClinicScottsdale, Arizona  
Gabrail Cancer CenterCanton, Ohio  44718
UCSD Moores Cancer CenterLa Jolla, California  93093