Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Glioma

Nausea

Vomiting

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Signs and Symptoms, Digestive

Neuroepithelioma

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Ondansetron

Temozolomide

Rolapitant

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.

Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.

Mary Lou Affronti, DNP, RN, ANP, MHSc

The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.

All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and 75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of two antiemetic treatment sequences: sequence A that involves administration of ondansetron alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for 3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one primary endpoint: complete response (CR) rate. Participation in this study may result in reduced chemo-radiation induced nausea and vomiting, however, risks include the common side effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis, and anemia.

Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide

Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide

The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.

The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?"

Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.

Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.

Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.

Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.

Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.

Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.

The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.

The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.

Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.

Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.

The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.

Duke University

Weeks 1-3

Rolapitant: single 180 mg dose by mouth

Ondansetron: 8 mg by mouth daily

Period 1 Rolapitant + Ondansetron

Weeks 1-3

Ondansetron: 8 mg by mouth daily

Period 1 Ondansetron

Weeks 4-6

Rolapitant: single 180 mg dose by mouth

Ondansetron: 8 mg by mouth daily

Period 2 Rolapitant + Ondansetron

Weeks 4-6

Ondansetron: 8 mg by mouth daily

Period 2 Ondansetron

Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.

Rolapitant: single 180 mg dose by mouth

Ondansetron: 8 mg by mouth daily

Sequence A

Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.

Rolapitant: single 180 mg dose by mouth

Ondansetron: 8 mg by mouth daily

Sequence B

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

James Herndon II, Ph.D.

Four participants in each group did not complete MATs for the first two weeks.

Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)

Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.

Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes

Sequence A: Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.

Sequence B: Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.

Rolapitant: single 180 mg dose by mouth

Ondansetron: 8 mg by mouth daily

Sequence A and Sequence B

Participants who provided treatment preference data.

Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone

Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 3.

Week 3 Patient Satisfaction: Effectiveness

Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 3.

Week 3 Patient Satisfaction: Convenience

Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 3.

Week 3 Patient Satisfaction: Overall Satisfaction

Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 6.

Week 6 Patient Satisfaction: Effectiveness

Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 6.

Week 6 Patient Satisfaction: Convenience

Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 6.

Week 6 Patient Satisfaction: Overall Satisfaction

Participants who completed MATs for the first two weeks.

Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks

Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes

Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks

Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes

Participants who completed MATs for six weeks and complied with treatment.

Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks

Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks

Participants who remained on study and returned medication logs.

Ondansetron Medication Compliance Weeks 1-3

Participants who remained on study without schedule changes and returned medication logs.

Spots Global Cancer Trial Database for 00076418

Every month we try and update this database with for 00076418 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 00076418

Every month we try and update this database with for 00076418 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 00076418 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.