Table 2.
Summary of all grades (2–5) toxicities observed in > 10% of patients that were considered possibly, probably, or definitely related to study related intervention.
| Treatment related (possible, probable, or definite) toxicities that occurred in > 10% of patients | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Toxicity | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | |||||||||||
| Irinotecan | 150 mg/m2 | 150 mg/m2 | 180 mg/m2 | 150 mg/m2 | 180 mg/m2 | |||||||||||
| Reovirus | 1 X 1010 TCID50 | 3 X 1010 TCID50 | 3 X 1010 TCID50 | 3 X 1010 TCID50 | 3 X 1010 TCID50 | |||||||||||
| Bevacizumab | None | None | None | 5 mg/kg | 5 mg/kg | |||||||||||
| n | 3 | 12 | 6 | 7 | 8 | |||||||||||
| Grade | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | 5 | 2 | 3 | 4 | 2 | 3 | 4 |
| Myelosuppression | ||||||||||||||||
| Neutropenia | 1 | 5 | 1 | 1 | 3 | 3 | 1 | 3 | 3 | |||||||
| Anemia | 3 | 1 | 1 | 2 | 1 | 2 | 3 | |||||||||
| Thrombocytopenia | 1 | 1 | 3 | 1** | 1 | |||||||||||
| Infection | 2 | 1 | 1** | 1 | ||||||||||||
| GI Symptoms | ||||||||||||||||
| Diarrhea | 4 | 2 | 1 | 1 | 3 | 2 | ||||||||||
| Constipation | 1 | 1 | 2 | |||||||||||||
| Nausea | 1 | 2 | 1 | 2 | ||||||||||||
| Vomiting | 2 | 1 | 1 | 2 | 1 | |||||||||||
| Stomatitis# | 1 | 1 | ||||||||||||||
| Anorexia | 1 | 2 | 2 | 1 | ||||||||||||
| Dehydration | 1 | |||||||||||||||
| Flu like symptoms | ||||||||||||||||
| Fatigue | 2 | 5 | 2 | 3 | 3 | 3 | 2 | |||||||||
| Pyrexia | 1 | 1 | 1 | |||||||||||||
| Dehydration | 1 | |||||||||||||||
| Musculoskeletal$ | 2 | 4 | 1 | |||||||||||||
| Generalized | ||||||||||||||||
| Dizziness | 3 | 2 | ||||||||||||||
| Insomnia | 4 | 2 | 1 | 2 | ||||||||||||
| Dyspnea | 1 | 1 | ||||||||||||||
| DVT | 1 | 1 | 2 | |||||||||||||
| HTN | 1 | 1 | 1 | 1 | 3 | |||||||||||
| Epistaxis | 1 | 1 | 1 | 3 | 1 | |||||||||||
| Proteinuria | 2 | 3 | 2 | |||||||||||||
includes oropharyngeal pain, mucositis
includes arthralgias, back pain, myalgias, extremity pain, headaches
Dose limiting toxicity