Status:
COMPLETED
PV-10 Chemoablation of Recurrent Breast Carcinoma
Lead Sponsor:
Provectus Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
PHASE1
Brief Summary
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of recurrent breast carcinoma. This study will also include a preliminary assessment of response ...
Detailed Description
This is a single center, open label, ascending dose study. Subjects with at least one recurrent, histologically confirmed measurable soft tissue breast carcinoma who are candidates for lumpectomy (rem...
Eligibility Criteria
Inclusion
- Biopsy confirmed recurrent soft tissue breast carcinoma
- At least one measurable target lesion at least 0.5 cm and no more than 3 cm in longest diameter
- Performance Status: Karnofsky 70-100% or ECOG 0-2
- Life Expectancy: At least 6 months
- Hematopoietic:
- White blood cell count (WBC) at least 3000/mm3
- Absolute neutrophil count (ANC) at least 1.5 (1,500/mm3)
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm3
- Coagulopathy: International Normalized Ratio (INR) at least 1.5.
- Renal Function: Creatinine = 0.05-0.11 mmol/L
- Hepatic Function:
- Bilirubin = 3-21 umol/L
- AST/ALT ≤ 3 times the upper limit of normal (ULN)
- Cardiovascular Function: No major cardiovascular disease
- Thyroid Function: T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits
- Immunological Function: Adequate immune system function in the opinion of the investigator
Exclusion
- Radiation therapy to study lesions within 4 weeks
- Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin)
- Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks
- Investigational agents within 4 weeks (or 5 half-lives)
- Anti-tumor vaccine therapy within 12 weeks
- Concurrent illness:
- Severe diabetes or extremity complications due to diabetes
- Significant concurrent disease or illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the investigator, compromise subject safety or compliance or interfere with interpretation of study results
- Thyroid autoregulatory dysfunction, including thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, prior radioiodine- or surgically-treated Graves' hyperthyroidism, or cystic fibrosis
- Pregnancy or fertile female subjects who are not using effective contraception, or who are lactating
- Known or suspected brain metastases or spinal cord compression.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00237354
Start Date
October 1 2005
End Date
July 1 2008
Last Update
October 24 2008
Active Locations (1)
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1
Canterbury BreastCare
Christchurch, New Zealand