A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma
Collecte de données
Maladies du sein+3
+ Néoplasmes du sein
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2005
Date à laquelle le premier participant a commencé l'étude.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 (removal of the lesion from the site of recurrence in the breast or at another site) or mastectomy will receive a single intralesional injection of PV-10 into a single target lesion to uniformly infiltrate the target lesion and up to a 0.5 cm margin at a dose of up to 1.0 mL/cc lesion volume. Systemic and locoregional adverse events will be monitored over the study interval. Subject accrual and PV-10 administration will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.15 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 85 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * 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 Criteria: * 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.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site