Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors

Inclusion Criteria:

• Diagnosis of relapsed or refractory solid tumors

  • Must have had histologic verification of malignancy at original diagnosis or relapse
  • Disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • No primary central nervous system (CNS) tumors or lymphomas
• Measurable or evaluable disease
• No known germline mutations affecting Ras activation (e.g., cardio-facial-cutaneous syndrome, Noonan syndrome, Costello syndrome)
• No known metastatic CNS disease
• Karnofsky performance status (PS) 50-100% for patients > 16 years of age OR Lansky PS 50-100% for patients ≤ 16 years of age
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Platelet count ≥ 100,000/mm³ (transfusion independent, defined as ≥ 7 days since platelet transfusion prior to enrollment)

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR serum creatinine based on age and/or gender as follows:

  • 0.8 mg/dL (3 to < 6 years of age)
  • 1.0 mg/dL (6 to < 10 years of age)
  • 1.2 mg/dL (10 to < 13 years of age)
  • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
  • 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
• Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 times upper limit of normal (ULN)
• Alanine aminotransferase (ALT) =< 110 U/L (ULN for ALT is 45 U/L)
• Serum albumin ≥ 2 g/dL
• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study

• Pulmonary function tests (PFTs), including diffusion capacity of carbon monoxide (DLCO), normal for patients with respiratory symptoms (e.g., dyspnea at rest, known requirement for supplemental oxygen)

  • Full PFTs not required for patients without respiratory symptoms
• Seizure disorder allowed provided it is well controlled with anticonvulsants
• Nervous system disorders (NCI CTCAE v. 4) resulting from prior therapy must be ≤ grade 2
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No uncontrolled infections
• No chronic diarrhea, urinary incontinence during the day or at night, or patients who are not completely toilet trained
• No household contacts (living with patient during the 4 weeks of treatment) who are pregnant, immunosuppressed, or infants < 3 months of age
• No patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
• No known HIV infection, hepatitis B or C, or any pre-existing infection
• Recovered from acute toxic effects of all prior anti-cancer chemotherapy and immunizations
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
• At least 14 days since prior long-acting growth factor (e.g., Neulasta) or ≥ 7 days since short-acting growth factor
• At least 7 days since prior biologic agent (anti-neoplastic agent)
• At least 16 weeks since prior immunotherapy (e.g., tumor vaccines)
• At least 3 half-lives since prior monoclonal antibody

• At least 2 weeks since prior palliative radiotherapy (small port)

  • At least 24 weeks since prior total body irradiation, craniospinal radiotherapy, or ≥ 50% of radiotherapy to the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiation
• At least 12 weeks since prior stem cell transplant or infusion with no evidence of active graft-vs-host disease

• More than 7 days since prior viral immunizations, including influenza vaccine

  • Patients may not receive any viral immunizations after enrolling on study and for ≥ 28 days after their last planned Reolysin infusion

• More than 7 days since prior corticosteroids, immune modulators, or antiviral therapy

  • Intravenous immune globulin (IVIG) may not be given within 2 weeks of Reolysin administration
• No prior viral-based anti-neoplastic therapies
• No other concurrent investigational drugs
• No other concurrent anticancer agents including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
• No concurrent cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease after bone marrow transplant or organ rejection after transplant
• No concurrent corticosteroids (with the exception of hydrocortisone as a treatment for anaphylaxis), immune modulators, antiviral therapy, or IVIG
• No concurrent acetaminophen