Know Cancer

or
forgot password

A Phase 1b Dose Escalation Study of JX-594 (Thymidine Kinase-Inactivated Vaccinia Virus Plus GM-CSF) Administered by Biweekly (Every Two Weeks) Intravenous Infusion in Patients With Metastatic, Refractory Colorectal Carcinoma


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

Thank you

Trial Information

A Phase 1b Dose Escalation Study of JX-594 (Thymidine Kinase-Inactivated Vaccinia Virus Plus GM-CSF) Administered by Biweekly (Every Two Weeks) Intravenous Infusion in Patients With Metastatic, Refractory Colorectal Carcinoma


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion

Outcome Description:

Any of the following treatment related adverse events: Grade 4 toxicity, Grade 3 hematologic toxicity for > 5 days, Grade 3 non-hematologic toxicities persisting for > 7 days except for flu-like symptoms that respond to standard therapies.

Outcome Time Frame:

DLT evaluations through 14 days following last JX-594 treatment

Safety Issue:

Yes

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

JX594-IV-CRC014

NCT ID:

NCT01380600

Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Colorectal
  • Vaccinia
  • Vaccinia Virus
  • JX-594
  • Jennerex
  • Colorectal Carcinoma
  • Colorectal cancer
  • Colon Cancer
  • Rectal Cancer
  • Pexa-Vec
  • Carcinoma
  • Colorectal Neoplasms
  • Vaccinia

Name

Location