Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

Stopped early · Phase 2

Conditions studied: Breast Cancer Nos Metastatic Recurrent

In brief

Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.

Key facts

Study ID

NCT01703754

Run by

Alaunos Therapeutics

People needed

12

Starts

2013-04-04

Expected to finish

2014-08-07

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥ 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists.
• Failed or progressed on at least 1 prior systemic chemotherapy regimen ± biologic/experimental therapy (if first-line therapy, failure or progression during the first 30 days).
• Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
• A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1.
• Eastern Cooperative Oncology Group performance status 0, 1, 2
• Male and female subjects must agree to use a highly reliable method of birth control.
• Adequate bone marrow reserve as indicated by:
• Absolute neutrophil count > 1500/μL (without use of growth factors within 7 days)
• Absolute lymphocyte count > 700/μL (without use of growth factors within 7 days)
• Platelet count > 100,000/mm3 (without transfusion in prior 7 days)
• Hemoglobin > 9.0 g/dL (without transfusion in prior 7 days)
• Estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation: eGFR ≥ 60 mL/min/1.73 m2
• Adequate liver function as evidenced by the following:
• Bilirubin ≤ 1.5 times the upper limits of normal (ULN)
• Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5×ULN, in the case of liver metastases ≤ 5×ULN

You may not qualify if…

• Subjects with human epidermal growth factor receptor 2 (HER2)/neu-positive (immunohistochemistry [IHC]) 3+ or fluorescence in situ hybridization-amplified) breast tumors who are eligible for, but who have not received HER2-targeted therapy (eg, trastuzumab)
• Concomitant anticancer therapies
• Prior therapies discontinuation periods:
• Radiation within 3 weeks of enrollment
• Chemotherapy within 4 weeks of enrollment
• Nitrosoureas within 6 weeks of enrollment
• Biologic therapy and/or immunomodulatory therapy, checkpoint inhibitors within 6 weeks of enrollment
• No washout period is required for endocrine therapy
• Radiation therapy encompassing >25% of bone marrow
• History of bone marrow or stem cell transplantation
• Any congenital or acquired condition leading to inability to generate an immune response
• Immunosuppressive therapy:
• Systemic immunosuppressive drugs including corticosteroids (prednisone equivalent >10 mg/day)
• Immune suppression/requiring immunosuppressive drugs, including organ allografts
• Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
• Major surgery within 4 weeks of study treatment
• History of prior malignancy, unless the prior malignancy was diagnosed and definitively treated ≥5 years previously with no subsequent evidence of recurrence
• Subjects with brain or subdural metastases, unless local therapy has completed and corticosteroids have been discontinued for this indication for ≥4 weeks before starting study treatment.
• Any medications that induce, inhibit, or are substrates of cytochrome P450 (CYP450) 3A4 within 7 days prior to the first dose of study drug
• Subjects with meningeal carcinomatosis
• Known significant hypersensitivity to study drugs or excipients
• History of malabsorption syndrome or other condition that would interfere with enteral absorption
• International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] <1.5 x ULN, if not therapeutically anticoagulated.
• New York Heart Association (NYHA) Class II or greater congestive heart failure OR active ventricular arrhythmia requiring medication
• Any other unstable or clinically significant concurrent medical condition

Where it is running

• Baptist Cancer Institute — Jacksonville, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Billings Clinic — Billings, Montana, United States
• Signal Point Clinical Research Center — Middletown, Ohio, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• The Jones Clinic, PC — Germantown, Tennessee, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Evergreen Hematology & Oncology — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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