Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT01048892
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT01048892
Study Brief:
Protocol Section:
NCT01048892