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A Phase I, Open-Label, Dose-Escalating Study Of The Safety, Tolerability, And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus, NV1020, In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase I, Open-Label, Dose-Escalating Study Of The Safety, Tolerability, And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus, NV1020, In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver


OBJECTIVES:

- Determine the safety and maximum tolerated dose of a single intrahepatic NV1020
injection in patients with hepatic metastases from colon cancer that has failed
first-line chemotherapy.

- Determine the tolerability of this drug in these patients.

- Determine preliminarily the anti-tumor activity of this drug in these patients.

- Assess the immunogenicity of NV1020 in these patients.

OUTLINE: This is a dose escalation study.

Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the
aid of hepatic arteriography.

Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients
experience dose-limiting toxicity.

Patients are followed at 1, 2, and 3 months post injection. Patients may participate in a
separate long term (up to 1 year) follow-up study for continued assessment and monitoring.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon

- At least 3 metastatic hepatic lesions involving both lobes

- No extrahepatic disease

- Failed first-line combination chemotherapy of fluorouracil plus either leucovorin
calcium or irinotecan

- Herpes simplex virus type-1 seropositive

- Candidate for intrahepatic arterial infusion pump placement

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 9.0 g/dL

- No history of any blood clotting disorder (e.g., hemophilia)

Hepatic:

- Transaminases no greater than 3 times upper limit of normal

- Bilirubin no greater than 2.0 mg/dL

- No active hepatitis

- No history of hepatic fibrosis, cirrhosis, or hemochromatosis

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- All patients must use effective barrier contraception during and for at least 6
months after study

- HIV negative

- No active herpes infection

- No other active uncontrolled infection

- No prior weight loss of more than 10 lbs within the past month

- No history of alcohol or other substance abuse

- No concurrent unstable and/or severe medical or psychological condition

- No history of any other medical or psychological condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy (e.g., interleukin-2, interleukin -12, or
interferon)

- No prior gene transfer therapy

- No prior therapy with cytolytic virus of any type

- No concurrent immunotherapy during and for 28 days after study therapy

- No concurrent vaccines during and for 28 days after study therapy

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No concurrent chemotherapy during and for 28 days after study therapy

Endocrine therapy:

- No concurrent systemic steroids during and for 28 days after study therapy

Radiotherapy:

- No prior radiotherapy to the liver

- No concurrent radiotherapy during and for 28 days after study therapy

Surgery:

- At least 2 weeks since prior surgery

Other:

- At least 30 days since prior participation in investigational study

- No concurrent antiviral agent active against herpes simplex virus (e.g., acyclovir,
valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, or cidofovir) during
and for 28 days after study therapy

- No concurrent immunosuppressive agents (e.g., cyclosporine) during and for 28 days
after study therapy

- No other concurrent investigational or anti-cancer agents during and for 28 days
after study therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Yuman Fong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-00022

NCT ID:

NCT00012155

Start Date:

October 2000

Completion Date:

December 2009

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • adenocarcinoma of the colon
  • liver metastases
  • Adenocarcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021