ADVL1014: A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors
What is the purpose of this study?
This phase I trial is studying the side effects and the best dose of viral therapy in treating young patients with relapsed or refractory solid tumors.
Who can participate?
- 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 CNS tumors or lymphomas
- Measurable or evaluable disease
- Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity (maximum of one per cohort)
- Patients must meet ANC and platelet count (may receive transfusions provided they are not be known to be refractory to red cell or platelet transfusion)
- No known germline mutations affecting Ras activation (e.g., cardio-facio-cutaneous syndrome, Noonan syndrome, Costello syndrome)
- No known metastatic CNS disease
What is involved?
This is a multicenter, dose-escalation study of wild-type reovirus (Reolysin).
Patients receive Reolysin IV over 60 minutes once daily on days 1-5. Some patients also receive oral cyclophosphamide on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood, saliva, and stool specimen collection at baseline and periodically during study for pharmacokinetic and neutralizing antibody studies by RT-PCR. Archived tumor tissue samples (if available) are also analyzed for biomarker studies.
After completion of study treatment, patients are followed up periodically for up to 1 year.
What are the benefits?
A virus called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells.
What are the risks and discomforts of the study?
Do participants receive pay, compensation or reimbursement?