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Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301106
First received: March 8, 2006
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.


Condition Intervention Phase
Breast Cancer
Metastatic Cancer
Biological: adenovirus-mediated human interleukin-12
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 36
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

  • Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
  • Determine tumor responses produced by this regimen.
  • Determine immune responses induced by this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive adenovirus-mediated human interleukin-12 via percutaneous intratumoral needle puncture under ultrasound guidance on day 1.

Cohorts of 3-6 patients receive escalating doses of adenovirus-mediated human interleukin-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed* breast adenocarcinoma metastatic to the liver

    • Solitary or multiple hepatic metastases

      • No malignant involvement of > 40% of the estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection
  • Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
  • At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
  • Extrahepatic metastasis allowed
  • No solitary hepatic metastasis eligible for liver resection
  • No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Granulocyte count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • PT ≤ 14.5 sec
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Transaminases ≤ 2.5 times ULN
  • Karnofsky performance status ≥ 70%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
  • No active infection or serious intercurrent medical illness
  • No HIV infection
  • Life expectancy ≥ 16 weeks
  • No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer
  • At highest dose level, patient must weigh ≥ 30 kg

PRIOR CONCURRENT THERAPY:

  • No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry

    • Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment
  • No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301106

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Chair: Max W. Sung, MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00301106     History of Changes
Other Study ID Numbers: CDR0000456626, MTS-GCO-97-779, MTS-9911-358, MTS-A-8200
Study First Received: March 8, 2006
Last Updated: February 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
liver metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Breast Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases
Interleukin-12
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014