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A Phase II Single Arm Trial of Palonesetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma Patients Receiving Irinotecan in Combination With Bevacizumab


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Cancer

Thank you

Trial Information

A Phase II Single Arm Trial of Palonesetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma Patients Receiving Irinotecan in Combination With Bevacizumab


Before you receive the drug, you will have a physical exam and blood tests to determine you
are able to take part. If you choose to participate in this study, you will sign a consent
form. You will then get a medication called Palonosetron. Palonosetron will be given into
a vein. This will take fifteen minutes. You will be given the Palonosetron and
Dexamethasone 30 minutes before your first dose of Irinotecan and Bevacizumab chemotherapy.
The total expected duration of your participation is 57 days. You will also be asked to
complete 4 questionnaires asking questions about nausea and vomiting, your daily functioning
and fatigue. You will be asked to complete these questionnaires before to starting your
chemotherapy, the day you start your chemotherapy and for the next 4 days after receiving
chemotherapy, for a total of 6 times. You will be asked to complete this set of
questionnaires each of the 3 times that you receive chemotherapy during your 6-week
treatment cycle.

The other treatments you would normally receive for your brain tumor and your routine care
will not be affected by the study.


Inclusion Criteria:



In order to be included in the study, patients must meet all of the following criteria:

- Patients must have histologically confirmed diagnosis of primary malignant glioma
(glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic
oligodendroglioma) who are either chemotherapy naïve or non-naïve and scheduled to
receive Irinotecan/Bevacizumab chemotherapy.

- Patients with recurrent disease whose diagnostic pathology confirmed malignant glioma
(glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic
oligodendroglioma) will not need re-biopsy.

- Age > or = 18 years.

- Patient is scheduled to receive Irinotecan/Bevacizumab chemotherapy every 2 weeks for
one complete 6-week cycle.

- An interval of at least 6 weeks between prior surgical resection and study
enrollment.

- An interval of at least 4 weeks between prior radiotherapy and enrollment on this
protocol unless there is unequivocal evidence of tumor progression after radiotherapy
or chemotherapy.

- The lab values following the prior chemotherapy must return within normal limits
prior to study enrollment.

- Karnofsky > 60%.

- Hematocrit > 29%, absolute neutrophil count (ANC) > 1,500 cells/*l, platelets >
125,000 cells/*l.

- Serum creatinine < 1.5 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) and
bilirubin < 1.5 times upper limit of normal.

- Patients on corticosteroids must be 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 consent form approved by the Institutional Review Board prior to patient
entry.

- No evidence of hemorrhage on the baseline MRI or CT scan.

- If sexually active, patients will take contraceptive measures for the duration of the
treatments.

Exclusion Criteria:

Patients are excluded from this study if they meet any of the following criteria:

- Inability or unwillingness to understand or cooperate with study procedures.

- Received any intravenous drug with potential anti-emetic effect within 24 hours prior
to the start of study-designated chemotherapeutic agent or be scheduled to receive
any drug of this type (with the exception of administration of the
palonosetron/dexamethasone infusion solution) at any time during the trial, including
the following:

- 5 HT3 receptor antagonists;

- Dopamine receptor antagonists (metoclopramide);

- Phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine);

- Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide.
Diphenhydramine will be allowed if given for prophylactic treatment of
hypersensitivity reactions associated with the administration of taxanes;

- Haloperidol, droperidol, tetrahydrocannabinol, or nabilone; and

- Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone). Topical
or inhaled preparations are allowed;

- Previous participation in any clinical trial involving palonosetron (RS-25259 of
Syntex).

- Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea
(see Appendix 8.6) in the 24 hours preceding chemotherapy.

- Ongoing vomiting from any organic etiology.

- Will receive radiotherapy of upper abdomen or cranium within one week prior to or
during the study.

- Received palonosetron within 14 days prior to study enrollment (AloxiTM).

- Evidence of central nervous system (CNS) hemorrhage on baseline MRI on CT scan.

- Co -medication that may interfere with study results; e.g. immuno-suppressive agents
other than corticosteroids.

- Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to
the start of chemotherapy through 120 hours after the initiation of chemotherapy on
Study Day 1 (Study Day 6) is prohibited, with the exception of the study drug.
Corticosteroids will be allowed for treatment of cerebral swelling. Diphenhydramine
will be allowed only if given for prophylactic treatment of hypersensitivity
reactions associated with the administration of taxanes, as per the package insert
for these agents. Rescue medication for treatment of nausea and vomiting is permitted
after chemotherapy at the discretion of the investigator. The agent, dose, and time
of administration will be recorded in the patient diary.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Response for Chemotherapy Induced nausea and vomiting

Outcome Time Frame:

two days prior and the first four days of chemo treatment and daily for 57 days

Safety Issue:

No

Principal Investigator

Mary Lou Affronti, RN, MSN, ANP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00002273

NCT ID:

NCT00636805

Start Date:

May 2008

Completion Date:

January 2014

Related Keywords:

  • Brain Cancer
  • Aloxi
  • Brain Neoplasm, Primary
  • Brain Neoplasms, Malignant
  • Brain Neoplasms
  • Glioma

Name

Location

Duke University Medical CenterDurham, North Carolina  27710