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Cyclophosphamide for the treatment of progressive low-grade astrocytoma: a Pediatric Oncology Group phase II Study
R P Kadota1, L E Kun, J W Langston
1Pediatric Oncology Group, Chicago, Illinois, USA.
Insights
Cyclophosphamide (CPM) showed insufficient activity against pediatric low-grade astrocytoma. The phase II trial was closed early due to excessive progressive disease in children treated with CPM.
Area of Science:
- Pediatric Oncology
- Neuro-Oncology
Background:
- Low-grade astrocytomas are the most common brain tumors in children.
- Treatment options for progressive pediatric low-grade astrocytomas are limited.
Purpose of the Study:
- To evaluate the efficacy and safety of cyclophosphamide (CPM) in children with progressive low-grade astrocytoma.
- To report the results of a phase II clinical trial.
Main Methods:
- Fifteen pediatric patients with a median age of 39 months were enrolled.
- Four courses of intravenous CPM (1.2 g/m2) were administered every 3 weeks.
- Tumor locations included optic pathway, hypothalamus, and thalamus in 11 patients.
Main Results:
- Toxicity was primarily hematologic.
- One patient achieved a complete response, 8 had stable disease, and 5 had progressive disease (PD).
- The high rate of PD led to early study closure.
Conclusions:
- Cyclophosphamide (CPM) demonstrated insufficient anti-tumor activity for pediatric low-grade astrocytoma in this trial.
- Further patient accrual was not justified due to lack of efficacy.
Purpose:
Results of a phase II trial of cyclophosphamide (CPM) for children with progressive low-grade astrocytoma are reported.
Patients And Methods:
Fifteen patients with a median age of 39 months (range, 2 to 71) were included in this study. The tumors of 11 children were located in the optic pathway, hypothalamus, or thalamus. Four courses of intravenous CPM 1.2 g/m2 were administered every 3 weeks during the upfront window portion of this protocol. Subsequently, chemotherapy was to continue with CPM, vincristine, and carboplatin for 2 years.
Results:
By study design, the first 14 patients were centrally reviewed after completion of the initial 4 CPM courses. Toxicity was primarily hematologic. One patients had a complete response, 8 had stable disease, and 5 had progressive disease (PD). The excessive number of children with PD prompted study closure.
Conclusion:
CPM as used in this protocol showed insufficient activity against astrocytoma to justify further patient accrual.
