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A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Phase 2
18 Years
Not Enrolling
Astrocytoma, Glioma, Oligodendroglioma

Thank you

Trial Information

A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with
recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA).
Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days
(treatment cycle).

Baseline data (collected <14 days) was to consist of a neurological/oncological history,
neurological examination, height, weight, performance status, Quality Of Life FACT-L
questionnaire, laboratory studies to include complete blood count (CBC), differential,
platelets, prothrombin time (PT), complete metabolic panel (CMP), Lactose dehydrogenase
(LDH), and a pregnancy test, as well as a cranial Computerized Tomography/Magnetic Resonance
Imaging (CT/MRI) with and without contrast (to measure or evaluate the size and location of
the tumor before treatment).

Administered every 21 days was a dose of irinotecan (CPT-11), zofran/Kytril/Anzemet,
decadron, and intravenous (IV) atropine. At each cycle, patient exams and interviews as well
as lab results were to help the research team to determine the symptomatic side effects of
the treatment. Recorded past toxicities were to be compared with current side effects.

Between days 15-21 (within 7 days of next scheduled CPT-11 treatment) the following tests
were to be repeated - a neurological/oncological history and neurological examination,
weight, blood drawn (CMP, LDH), performance status, and Quality Of Life FACT-L
questionnaire. Also, a MRI (Cranial CT/MRI with and without contrast) was to be performed
for tumor assessments at week 9, 18, 27, 36, and after every nine weeks thereafter until
progression. Response was to be measured by a reduction in tumor size.

These supportive therapies were provided as necessary:

- Antiemetic Therapy

- Anticholinergics

- Loperamide (ImodiumĀ®)

- Growth Factors

- Other Concomitant Medications

Inclusion Criteria:

- Patients must have histological or neuroradiographic documented recurrent glioma
defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma.
All patients must have had prior pathologic confirmation of primary tumor histology.

- Patients must be > than or equal to 18 years old.

- Patients must have a Karnofsky performance score (KPS) of > or equal to 50

- Measurable disease per MacDonald criteria is required

- Patients must have a predicted life expectancy of at least 12 weeks

- Required initial laboratory data:

1. Absolute Neutrophil Count (ANC) > 1,500

2. Platelets > 100,000

3. Serum Creatinine < 2.0

4. Serum Bilirubin < 2.0

5. Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal

6. Pregnancy test for females with child-bearing potential negative

- Patients must sign and date an IRB approved informed consent form stating he or she
is aware of the neoplastic nature of the disease. Patient must willingly provide
written consent after being informed of the procedure to be followed, the
experimental nature of the therapy, alternatives, potential benefits, side effects,
risks, and discomforts. (Human protection committee approval of this protocol and
consent form is required).

- Patients must be willing and able to comply with scheduled visits, treatment plan,
and laboratory tests and accessible for follow-up.

- Patients must have been previously treated with both surgery and radiotherapy.

- Prior adjuvant and one salvage chemotherapy regimen is permitted.

- Prior stereotactic radiotherapy is permitted.

Exclusion Criteria:

- Patients have evidence of leptomeningeal spread of disease.

- Patients having been treated with 2 or more salvage regimens.

- Pregnant or breast-feeding women. With the exception of post-menopausal or infertile
women, a negative blood test for pregnancy is mandatory before entry on study.
Fertile persons refusing to use adequate contraceptives may not participate.

- Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic
diarrhea or presence of a bowel obstruction.

- Patients with a second active malignancy or diagnosis of other cancer within 3 years
of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma
of the cervix.

- Mentally incapacitated patients or psychiatric illness that would prevent the patient
from giving informed consent.

- Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high
blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial
infarction within the previous six months, or serious uncontrolled cardiac

- Known to be human immunodeficiency virus (HIV) positive or to have an acquired
immunodeficiency syndrome (AIDS) related illness.

- Patients with an active infection that is not adequately controlled with antibiotics.

- Patients with other severe concurrent disease, which, in the judgment of the
investigator, would make the patient inappropriate for entry into this study.

- Patients with a known sensitivity to any of the products to be administered during

- Patients currently enrolled in another clinical trial or patients who have
participated in a trial of an investigational device or drug within the last 30 days.

- Patients previously treated with CPT-11.

- Concurrent stereotactic radiotherapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Participants With Objective Response After 3 Cycles of Treatment

Outcome Description:

The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.

Outcome Time Frame:

3 cycles (21 day cycles)

Safety Issue:


Principal Investigator

Edward Pan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

October 2010

Related Keywords:

  • Astrocytoma
  • Glioma
  • Oligodendroglioma
  • Recurrent Anaplastic Astrocytoma
  • Mixed Malignant Glioma
  • Oligodendroglioma
  • Irinotecan
  • Brain tumor
  • Nitrosoureas
  • Brain and nervous system
  • Astrocytoma
  • Glioma
  • Oligodendroglioma



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612