Engineered Immune Effectors Against Cervical Cancer

Korábbi kezelés

• Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
• Previous exposure to mouse SCC antibody.
• Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
• Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).

Más betegség

• Patients with
  • cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;
  • cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.
• Serious active infection requiring i.v. antibiotics at during screening.
• Subject actively infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Laborértékek

• Inadequate bone marrow function with
  • absolute neutrophil count < 1,000/mm\^3;
  • platelet count < 100,000/mm\^3;
  • Hb < 9 g/dL.
• Inadequate liver and renal function with
  • serum (total) bilirubin > 1.5 x ULN;
  • AST \& ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
  • alkaline phosphatase > 2.5 x ULN;
  • serum creatinine >2.0 mg/dl (> 177 μmol/L);
  • urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.

Egyéb

• Pregnant or lactating females.

• Written, informed consent obtained prior to any study-specific procedures.
• Age older than 10 years.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Expected survival ≥ 12 weeks.
• Not pregnant, and on appropriate birth control if of childbearing potential.
• Evidence of high-risk HPV infection.
• Stage III-IV or recurrent cervical cancer.
• Initial hematopoietic reconstitution with
  • neutrophils (ANC) ≥ 1,000/mm\^3;
  • platelet (PLT) ≥ 100,000/mm\^3.
• Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
  • serum creatinine ≤ 2×ULN;
  • serum bilirubin ≤ 2×ULN;
  • AST/ALT ≤ 2×ULN;
  • ALKP ≤ 5×ULN;
  • serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
• Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.