Status:
COMPLETED
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eisai Inc.
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
1\. Purpose and objective: 1. To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation...
Detailed Description
We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ). ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Karnofsky ≥ 60%;
- Hematocrit \> 29%, absolute neutrophil count (ANC) \> 1,000 cells/\*1, platelets \> 100,000 cells/\*I;
- Serum creatinine \< 1.4 mg/dl; serum glutamate oxaloacetate transaminase (SGOT) and bilirubin \< 1.5 times upper limit of normal;
- 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;
- Signed informed consent approved by the Institutional Review Board prior to patient entry;
- If sexually active, patients w8ill take contraceptive measures for the duration of the treatments.
Exclusion
- Pregnancy or breastfeeding;
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids;
- Inability or unwillingness to cooperate with the study procedures;
- Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting is permitted after radiation therapy at the discretion of the investigator. The agent, dose, and time of administration will be recorded in the patient diary;
- Previous participation in any clinical trial involving palonosetron;
- Any vomiting, retching, or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy;
- Ongoing vomiting from any organic etiology;
- Will receive radiotherapy of upper abdomen within one week prior to or during the study;
- Received palonosetron within 14 days prior to study enrollment;
- Prior and Concomitant Medications for Prevention/Treatment of Nausea and Vomiting;
- Prior and Concomitant Cancer Chemotherapy and Radiotherapy.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00900757
Start Date
August 1 2009
End Date
December 1 2012
Last Update
August 28 2019
Active Locations (1)
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1
The Preston Robert Tisch Brain Tumor Center at Duke
Durham, North Carolina, United States, 27710