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Malignant GliomaPhase 2NCT01952886

Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

A Phase 2 study testing Granisetron and Ondansetron in people with Malignant Glioma, run by Duke University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess patient satisfaction, the efficacy and compliance of granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant temozolomide (TMZ). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Glioma
What is being tested?
Granisetron and Ondansetron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento Sep 2014
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed diagnosis of malignant glioma (Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who may or may not be chemotherapy naïve and who are scheduled to receive radiotherapy (for a total of 60 GY) and concomitant daily temozolomide therapy (at a dose of 75 mg/m2 for one complete six week cycle).
  • Age ≥ 18 years
  • Karnofsky ≥ 60%
  • Hematocrit > 29%, ANC >1,000 cells/mm3, platelets > 100,000 cells/ mm3
  • Serum creatinine < 1.4 mg/dl, serum 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
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  • Ability and willingness to give informed consent
  • If sexually active, patients will take contraceptive measures for the duration of the treatments
  • Negative serum pregnancy test 48 hours prior to beginning study drug

Who cannot join

  • Pregnancy or breastfeeding
  • Co-medication that may interfere with study results; e.g., immune-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
  • Previous participation in any clinical trial involving granisetron
  • Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy
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  • Ongoing vomiting from any organic etiology
  • Radiotherapy of abdomen within one week prior to or during the study
  • Received granisetron within 14 days prior to study enrollment
  • Prior and concomitant cancer chemotherapy and radiotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Randomized Cross-over Study to Evaluate Patient Satisfaction, Efficacy and Compliance of Granisetron Patch vs. Ondansetron in Malignant Glioma Patients Receiving Standard Radiotherapy (RT) and Concomitant Temozolomide (TMZ)

The purpose of this study is to assess patient satisfaction, the efficacy and compliance of granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing compliance.

All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will received the other medication. The granisetron transdermal delivery system (supplied as a 52 cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out questionnaires regarding the effectiveness of the medication and their satisfaction, and which anti-emetic they prefer.

Safety will be assessed throughout the six weeks of radiation by the clinical research nurse using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be included in analyses of treatment preference. However, all other efficacy and safety analyses will include all subjects who received ondansetron or GTDS.

Read the detailed description

The primary objective of this study is to assess whether malignant glioma patients receiving radiation therapy and concomitant TMZ are more satisfied with ondansetron or granisetron patch for the prevention of nausea and vomiting. The secondary objectives are 1) to compare the efficacy and compliance of granisetron patch and ondansetron in the prevention of nausea and vomiting during the 6 weeks of RT and concomitant TMZ, and 2) to assess the safety of the granisetron patch in preventing radiation induced nausea and vomiting in primary glioma patients receiving RT and TMZ.

All eligible subjects should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of temozolomide daily for a total of six weeks. Subjects will be randomized to receive one of two treatment sequences of antiemetic therapy for the prevention of nausea and vomiting associated with RT and concomitant TMZ. Sequence #1 involves administration of ondansetron for 3 weeks followed by the use of granisetron patch for 3 weeks; whereas sequence #2 involves the use of the granisetron patch for 3 weeks followed by 3 weeks of ondansetron. Toxicity will be assessed each week of radiation therapy based on the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The subject will be asked to complete the modified MASCC Antiemesis Tool (MAT) questionnaire at baseline, and on days 2, 4, and 7 of each week of radiation therapy, as well as to record the use of all study medication and any antiemetic rescue medication taken daily. At the end of the weeks 3 \& 6, the subject will be asked to fill out a Treatment Satisfaction Questionnaire for Medication and will be asked at the end of week 6 to choose which antiemetic they prefer.

Being tested
Granisetron, Ondansetron
Keywords
malignant glioma, antiemetic, ondansetron, granisetron, Preston Robert Tisch Brain Tumor Center, Pro00041233, Duke
Medical subject headings
Glioma

What participants receive

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

  • GranisetronDrug

    Also called Kytril

  • OndansetronDrug

    Also called Zofran, Zuplenz

Study groups in NCT01952886
Study groupRoleWhat they receive
Granisetron patchExperimentalGranisetron transdermal delivery system (supplied as a 52 cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week.
Receives: Drug: Granisetron
Ondansetron tabletActive comparatorOndansetron 8 mg oral tablet is prescribed for once a day.
Receives: Drug: Ondansetron

What is being measured

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

  1. Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill

    The percentage of subjects who prefer GTDS over Ondansetron pills as determined by the response to the question "Which nausea medication was I most satisfied with?"

    Measured: first 2 weeks after starting study

Secondary outcomes (4)

  1. Complete response (CR) rate of Granisetron Transdermal Delivery System (GTDS) compared to Ondansetron pill

    A comparison of the CR rate associated with GTDS and that associated with ondansetron. The CR rate is defined as the proportion of subjects with no emetic episode or use of rescue medication while receiving study medication, radiation and concomitant temozolomide during weeks 1 and 2.

    Measured: first 2 weeks after starting study

  2. Subject Compliance with Granisetron Transdermal Delivery System (GTDS) and Ondansetron pills

    The compliance rate will be measured as the percentage of days that GTDS or ondansetron pill were used during weeks 1 and 2 according to medication instructions

    Measured: 2 weeks

  3. Number of subjects experiencing a grade ≥3 treatment-related toxicity

    The number of subjects experiencing a grade ≥3 treatment-related toxicity during weeks 1 and 2. Adverse events will be assessed using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

    Measured: 2 weeks

  4. Patient satisfaction from the Treatment Satisfaction Questionnaire for Medication (TSQM-9 )

    A patient satisfaction score will be computed based upon responses to the TSQM-9. The score will be based on perceived effectiveness, convenience, and global satisfaction. Scores are 0-100, with higher scores indicating higher satisfaction. Subjects complete this questionnaire after patch and pill treatment at the end of weeks 1 and 2.

    Measured: 2 weeks

Timeline

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

  1. First posted30 Sep 2013 (estimated)
  2. Primary completionSep 2014

Why it stopped: Lack of approval and funding from company

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952886
Sponsor's protocol ID
Pro00041233
Status last verified
Sep 2014
First submitted
25 Sep 2013
Last updated
22 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Granisetron and Ondansetron 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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Sep 2014. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill (time frame: first 2 weeks after starting study). 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 NCT01952886.

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 22 Sep 2014.

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