Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

NCT00900757 | Completed Phase 2 Results

• 1 other identifier: Pro00015573
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Purpose and objective:

1. 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 (RT) and concomitant temozolomide (TMZ).
2. 2.To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ
3. 3.To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ.

Conditions

Malignant Glioma

Keywords

Primary Glioma; Palonosetron; Standard Radiotherapy; Temozolomide

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (4)

• Complete Response

  6 weeks

• Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment

  6 weeks

• Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)

  6 weeks

• Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)

  6 weeks

Study Arms (1)

Palonosetron

EXPERIMENTAL

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

Drug: Palonosetron (PALO)

Interventions

Palonosetron (PALO) DRUG

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.

Also known as: Aloxi

Palonosetron

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Eisai Inc.: collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mary Lou Affronti
• Organization: Duke University Medical Center

mary.affronti@dm.duke.edu

919-684-6239

Study Officials

• Mary Lou Affronti, RN, MSN, ANP

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 28, 2019
• Results First Posted: April 1, 2014

Record last verified: 2014-03

Locations

US (1)