Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy

Korábbi kezelés

• Pregnancy and Breastfeeding:
  • Female patients who are pregnant or breast-feeding will not be entered in the study. A negative pregnancy test within 72 hours of starting therapy is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential must agree to use an effective contraceptive method for the duration of their study participation

Más betegség

• Patients with any uncontrolled, intercurrent illness including, but not limited to, uncontrolled infection
• Patients with symptomatic congestive heart failure (defined as Grade 2 or higher heart failure per CTCAE version 5.0)
• Known allergy to any component of CS or CSS therapy, as indicated

Laborértékek

• Patients with Renal Tubular Acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate ≤ 2 mg/dL (or < 0.8 mmol/L) without supplementation. Patients requiring electrolyte supplementation for RTA will be permitted if bicarbonate ≥16 mmol/L and phosphate > 2mg/dL after at least 7 days of stable supplementation regimen

Egyéb

• Patients on tacrolimus and/or sirolimus with levels of either targeted > 10 ng/mL

• Patients must be > 1 month and ≤ 39 years old at study enrollment
• Histologically proven, at time of diagnosis or relapse:
  • Stratum 1: Arm CS (Cisplatin/STS): Previously chemosensitive to cisplatin defined as an AFP drop of 1 log (90%) and/or an objective tumor response of 30% or greater on imaging while receiving cisplatin.
  • Stratum 2A: Cisplatin/STS/SAHA (CSS): Previously chemosensitive but with noted subsequent progression on cisplatin or initially chemoresistant to cisplatin (all other hepatoblastoma patients). Resistance to cisplatin is defined as rising alpha-fetoprotein (AFP) x 2 consecutive measurements or imaging progression including growth of known lesions or new lesions while patient is receiving a cycle of chemotherapy containing cisplatin or relapse noted within 3 months of last cisplatin administration.
  • Stratum 2B: CSS: Relapsed/refractory Wilms tumor, Germ Cell Tumor, or Neuroblastoma
• Patients must have a life expectancy of ≥ 8 weeks.
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study:
  • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study. Previous SAHA administration is permitted. Tacrolimus and Sirolimus with levels <= 10 ng/ml are not considered myelosuppressive.
  • Immunotherapy: Must not have received within 2 weeks of entry onto this study.
  • Radiation therapy (RT): greater than or equal to 2 weeks for local palliative RT (small port); greater than or equal to 6 months must have elapsed if prior craniospinal RT or if greater than or equal to 50% radiation of pelvis
• Patients may not be enrolled on another clinical trial or receiving any other investigational therapies (within 2 weeks prior to study enrollment).
• Organ Function Requirements
  • Adequate Bone Marrow Function Defined as:
  • Peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL
  • Platelet count greater than or equal to 75,000/uL (transfusion independent defined as no platelet transfusions within 7 days)
  • Hemoglobin greater than or equal to 8.0 g/dL (may receive red blood cell transfusions)
  • Adequate Liver Function Defined As:
  • Total OR direct bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and
  • Aspartate aminotransferase (AST) or Alanine transaminase (ALT) < 10x ULN
  • Adequate Renal Function Defined As:
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 30 mL/min/1.73 m2
• Baseline Audiology Requirements:
  • Subjects must have a successful audiology examination prior to enrollment. Patients may have Boston grade III or IV hearing loss and still be eligible to enroll as long as they did not receive 3 or more cycles of cisplatin during upfront therapy WITH sodium thiosulfate. There is no specific baseline hearing level/grade requirement beyond that to be eligible, but the baseline level of hearing must be clearly established and recorded