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

NCT00301106 | Terminated Phase 1 DMC

• 5 other identifiers: GCO 97-779MTS-GCO-97-779MTS-9911-358MTS-A-8200CDR0000456626
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Metastatic Cancer

Keywords

stage IV breast cancer; liver metastases

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Serial monitoring of tumor necrosis factor alpha (TNFα) levels

  up to 15 days

Secondary Outcomes (4)

• Tumor Response

  up to 2 months

• IL12 level Immune response

  up to 2 months

• IFNγ levels Immune response

  up to 2 months

• Immune response

  up to 2 months

Study Arms (1)

adenovirus-mediated human interleukin-12

EXPERIMENTAL

starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.

Biological: adenovirus-mediated human interleukin-12

Interventions

adenovirus-mediated human interleukin-12 BIOLOGICAL

The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/ 1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.

adenovirus-mediated human interleukin-12

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Max Sung: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Max W. Sung, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: October 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 2, 2017

Record last verified: 2017-01

Locations

US (1)