Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refracto… (NCT01048892) | Clinical Trial Compass
CompletedPhase 1
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
United States22 participantsStarted 2009-09
Plain-language summary
RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill even more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley virus-001 in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features.
Who can participate
Age range3 Years – 21 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Neuroblastoma
* Rhabdomyosarcoma
* Wilms tumor
* Retinoblastoma
* Adrenocortical carcinoma
* Carcinoid tumor
* Relapsed or refractory disease
* Measurable or evaluable disease
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* No known pulmonary tumors or metastases \> 5 cm, as evaluated by chest CT scan
* No clinically significant pulmonary and/or pericardial effusions (≥ grade 3), as evaluated by ECHO
* No primary CNS tumors or known metastatic CNS disease involvement
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age)
* Lansky PS 50-100% (for patients ≤ 16 years of age)
* Peripheral ANC ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as no platelet transfusions within a 7-day period before study enrollment)
* Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
* Creatine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
* ≤ 0.8 mg/dL (for patients 3 to 5 years of age)
* ≤ 1.0 mg/dL (for patients 6 to 9 years of age)
* ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
* ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)
* ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)
* ≤ 1.7 mg/dL (for male patients ≥ 16 years of age)
* Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times …