cancer.duke.edu/btc  
The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Adults  | A Phase II Single Arm Trial of Palonosetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma Patients Receiving Irinotecan in Combination with Bevacizumab

Purpose:
The purpose of this study is to determine effectiveness/ tolerability of Aloxi + Decadron in preventing acute chemotherapy induced nausea/vomiting in brain tumor patients during 1st 24hrs and 1st 5 days after CPT-11+ Avastin.

Design: 
Aloxi 0.25mg + Decadron 10mg given 30 min prior to each of 3 doses of CPT-11  and Avastin during a 6-week cycle (total time on study = 6 weeks).

Eligibility: 

  • GBM/AA/AO/Gliosarcoma
  • CPT-11 + Avastin only
  • 6 weeks since surgical resection
  • 4 weeks since XRT unless PD
  • KPS 60%
  • Hematocrit > 29%, ANC > 1,500 cells/*l, platelets > 125,000 cells/*l.
  • Serum creatinine < 1.5 mg/dl, serum SGOT and bilirubin < 1.5 times ULN.
  • For patients on corticosteroids, they must have been on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible.
  • No hemorrhage on baseline MRI or CT scan

Procedures:
Patients will receive 3 doses of Aloxi. Each dose will be administered via IV, 30 minutes prior to their scheduled CPT-11 and Avastin dose. Patients will complete surveys on days 1-5 following chemotherapy to describe symptoms related to nausea, vomiting, and fatigue.


 

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