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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide

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