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Malignant GliomaPhase 2NCT00900757

Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

A Phase 2 study testing Palonosetron (PALO) in people with Malignant Glioma, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (RT) and concomitant temozolomide (TMZ). 2. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Malignant Glioma
What is being tested?
Palonosetron (PALO)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUnited States
Study dates
Aug 2009to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Preston Robert Tisch Brain Tumor Center at Duke

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients Receiving Standard Radiotherapy and Concomitant Temozolomide

  1. Purpose and objective:
  2. 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).
  3. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ
  4. To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ.
  5. 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.
  6. 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.
Read the 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.

Being tested
Palonosetron (PALO)
Keywords
Primary Glioma, Palonosetron, Standard Radiotherapy, Temozolomide
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palonosetron (PALO)Drug

    Also called Aloxi

    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.

Study groups in NCT00900757
Study groupRoleWhat they receive
PalonosetronExperimentalSingle Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Receives: Drug: Palonosetron (PALO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (4)

  1. 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).

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00900757
Sponsor's protocol ID
Pro00015573
Status last verified
Mar 2014
First submitted
11 May 2009
Last updated
28 Aug 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palonosetron (PALO) in people with Malignant Glioma, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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