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Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Palonosetron (PALO)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malignant Glioma focused on measuring Primary Glioma, Palonosetron, Standard Radiotherapy, Temozolomide

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • The Preston Robert Tisch Brain Tumor Center at Duke

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palonosetron

Arm Description

Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)

Outcomes

Primary Outcome Measures

Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity
The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.

Secondary Outcome Measures

Complete Response
The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).
Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.
Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.

Full Information

First Posted
May 11, 2009
Last Updated
August 23, 2019
Sponsor
Duke University
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00900757
Brief Title
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Official Title
Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients Receiving Standard Radiotherapy and Concomitant Temozolomide
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Eisai Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
1. Purpose and objective: To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ). To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ. 2. Study activities and Population group: 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). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty subjects with gliomas will participate. 3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type and the most severe grade experienced. The complete response rate, defined as the proportion of patients with no emetic episode or use of rescue medication while receiving radiation and concomitant temozolomide, will be estimated with a 95% confidence interval.
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). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron approximately 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. After the start of radiation the type of rescue medication will be up to the investigator's discretion (however given the results of recent published phase II study by Navari et. al. we recommend using olanzapine for rescue medication). All patients will be given written informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
Primary Glioma, Palonosetron, Standard Radiotherapy, Temozolomide

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palonosetron
Arm Type
Experimental
Arm Description
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Intervention Type
Drug
Intervention Name(s)
Palonosetron (PALO)
Other Intervention Name(s)
Aloxi
Intervention Description
Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
Primary Outcome Measure Information:
Title
Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity
Description
The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Complete Response
Description
The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).
Time Frame
6 weeks
Title
Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Description
The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.
Time Frame
6 weeks
Title
Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Description
Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.
Time Frame
6 weeks
Title
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Description
Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Lou Affronti, RN, MSN, ANP
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Preston Robert Tisch Brain Tumor Center at Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

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