ADVL1014, A Phase 1 Dose Escalation Study of REOLYSIN, a Replication Competent Reovirus, in Pediatric Patients with Relapsed or Refractory Solid Tumors

Summary

REOLYSIN will be administered intravenously over 60 minutes daily for 5 consecutive days every 28 days for a total of 12 cycles.
For Dose Level 3 only- REOLYSIN will be administered intravenously over 60 minutes daily for 5 consecutive days will be administered in combination with cyclophosphamide given 50 mg/m2/day orally in the morning for 21 consecutive days. This cycle will repeat every 28 days.
A cycle of therapy is considered to be 28 days. A cycle may be repeated 11 times (12 cycles total), up to a total duration of therapy of 12 months.

Participant Eligibility

Age: Patients must be ≥ 3 years and ≤ 21 years of age (< 18 years of age at this institution) at the time of study enrollment.

Diagnosis: Patients with relapsed or refractory solid tumors, with the exception
of CNS tumors and lymphomas, are eligible. Patients must have had histologic
verification of malignancy at original diagnosis or relapse.

Disease Status: Patients must have either measurable or evaluable disease.

Therapeutic Options: Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.

Performance Level: Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age.

Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and immunizations.

Organ Function Requirements: Adequate bone marrow, renal, liver, pulmonary, neurologic and cardiac function.

All patients and/or their parent or legal guardian must sign a written informed consent.

All institutional, FDA, and NCI requirements for human studies must be met.