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A Phase I/II, Open-Label Study (With a Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort), to Evaluate the Safety and Anti-Tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-Line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Liver Neoplasms

Thank you

Trial Information

A Phase I/II, Open-Label Study (With a Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort), to Evaluate the Safety and Anti-Tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-Line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver


Inclusion Criteria:



1. Ability to understand and willingness to sign a written informed consent (includes
willingness to avoid physical intimacy during and for 2 weeks post NV1020 treatment)

2. 18 years or more of age

3. Colorectal adenocarcinoma histologically confirmed within one year prior to
enrollment in the study

4. Liver dominant metastases (CT-measurable lesions with less than 50% total liver
involvement), histologically confirmed

5. Failed conventional chemotherapy for metastatic disease

6. Candidate for additional chemotherapy

7. Karnofsky Performance Status 70% or greater

8. Life expectancy greater than or equal to 4 months, based on the investigator's
opinion

9. Seropositive for herpes simplex virus-1 (HSV-1)

10. Fecund females: negative for pregnancy test (urine or serum)

11. Effective double-barrier contraception for a minimum of 2 months following final
infusion of NV1020

Exclusion Criteria:

1. Dominant extrahepatic disease, including cerebral metastases, significant malignant
ascites or other extrahepatic metastases that are symptomatic, in critical locations
or otherwise likely to confound NV1020 evaluations, in the opinion of the
investigator

2. Seronegative for HSV-1

3. Significant active/unstable non-malignant disease or laboratory test (hematology and
chemistry) results that meet any of the following:

- White blood cell count (WBC) less than or equal to 3 x 10e3/mm3

- Absolute neutrophil count (ANC) less than or equal to 1.5 x 10e3/mm3

- Platelets less than or equal to 100,000/mm3

- Hemoglobin (Hgb) less than or equal to 9.0 g/dL

- Prothrombin time/partial thromboplastin time (PT/PTT) > upper limit of normal
(ULN)

- Serum creatinine > 2.0 mg/dL

- AST or ALT > 2.5 times ULN or total bilirubin > 1.5 times ULN

- Alkaline phosphatase > 2.5 times ULN

4. Chemotherapy < 4 weeks prior to the first NV1020 infusion (mitomycin or nitrosurea <
6 weeks)

5. Immunotherapy < 6 weeks prior to the first NV1020 infusion

6. Radiotherapy (external or internal) to the liver

7. Major surgery (excluding pump placement and cholecystectomy) less than or equal to 2
weeks prior to the first NV1020 infusion and the patient must be clinically stable.
Pump placement and cholecystectomy less than or equal to 1 week prior to the first
NV1020 infusion

8. Female who is pregnant or nursing

9. Patients wishing to conceive within 2 months after the last infusion of NV1020

10. Any investigational agent administered less than or equal to 4 weeks prior to NV1020
infusion

11. Acute HSV infection requiring systemic antiviral therapy or history of serious HSV
infection (e.g., ocular, encephalitic, etc.)

12. Active viral hepatitis (evidence for infection with hepatitis A, B or C viruses)

13. Known infection with HIV

14. Known hypersensitivity to any component of the NV1020 formulation

15. History of, or current, bleeding or coagulation disorder

16. History of significant hepatic fibrosis, cirrhosis, or hemachromatosis

17. History of malignancy other than colorectal cancer, within 5 years prior to start of
study participation, with the exception of in situ cervical or skin carcinoma

18. Active severe infection and any other concurrent disease or medical conditions that
are likely to interfere with the study, as judged by the investigator

19. Systemic corticosteroid administration < 4 weeks prior to starting NV1020 treatment

20. Prior treatment with NV1020 or other putative oncolytic viruses

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of adverse events and dose limiting adverse events

Outcome Time Frame:

Last patient out

Safety Issue:

Yes

Principal Investigator

Hoda Tawfik, PhD

Investigator Role:

Study Director

Investigator Affiliation:

MediGene

Authority:

United States: Food and Drug Administration

Study ID:

CT1030

NCT ID:

NCT00149396

Start Date:

July 2004

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • Liver Neoplasms
  • Colorectal cancer metastases to liver
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Colorectal Neoplasms
  • Rectum Cancer
  • Rectum tumors
  • Rectum carcinoma
  • Colon cancer
  • Colon tumors
  • Colon carcinoma
  • Rectum Neoplasms
  • Colon Neoplasms
  • Liver Neoplasms
  • Hepatic Neoplasms
  • Liver Tumors
  • Liver cancer
  • Hepatic Cancer
  • Hepatic tumors
  • metastatic to the liver
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Mary Crowley Medical Research CenterDallas, Texas  75246
University of California, San DiegoLa Jolla, California  92037-1709
University of Pittsburgh Cancer CenterPittsburgh, Pennsylvania  15232
University of VanderbiltNashville, Tennessee  37232