Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features

Status: Recruiting
Phase: Phase 1
Diagnosis: Pediatric Solid Tumors
NCT ID: NCT01048892 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-243

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Suzanne Shusterman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

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 upper limit of normal (ULN) - SGPT ≤ 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L) - Serum albumin ≥ 2 g/dL - Oxygen saturation > 92% on room air - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator - Completely toilet trained - No chronic diarrhea or urinary incontinence during the day or night, , and no in-dwellling urinary catheters - No uncontrolled infection - No known pregnant member of the household PRIOR CONCURRENT THERAPY: - Fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy - At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis - At least 3 months since prior stem cell transplantation or rescue (without TBI) - No evidence of active graft-vs-host disease - At least 6 weeks since other prior substantial bone marrow radiotherapy or treatment with therapeutic doses of MIBG - More than 3 weeks since prior myelosuppressive chemotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - More than 7 days since prior growth factor(s) that support platelet or white blood cell number or function - At least 7 days since prior biologic agents - At least 3 half-lives since prior monoclonal antibodies - More than 7 days since prior viral immunizations, including influenza - At least 42 days since the completion of any type of immunotherapy, e.g., tumor vaccines - No other viral immunizations after enrolling on study until 28 days after their last planned Seneca Valley virus-001 infusion or until documented viral clearance, whichever is longest - Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for the past 7 days - No other concurrent investigational drugs - No other concurrent anticancer agents (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy) - Prior treatment with Seneca Valley virus-001 is not allowed
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