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Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide

Objectives of study are to determine activity of combo of Irinotecan + Temozolomide & to
further characterize any toxicity associated w combo of Irinotecan + Temozolomide.
Temozolomide administered orally at 200mg/m2 in fasting state 1hr prior to CPT-11 infusion.
Temozolomide administered on day 1 of treatment cycle & every 24hrs thereafter for 5 days w
treatment cycles repeated every 6wks. Treatment cycles may be repeated up to maxi of 3
cycles until occurrence of either unacceptable toxicity/evidence of disease progression. At
end of 3rd cycle/if cycles are stopped early for toxicity or progression, subject will
undergo radiation therapy. CPT-11 administered intravenously in fasting state over 90min.
CPT-11 will begin 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11
administered on days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated
up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease
progression. Dose of CPT-11 will be based on whether pt is receiving CYP3A4-inducing
antiepileptic drugs due to increased drug clearance produced by these agents. For pts
receiving EIAEDs including phenytoin, fosphenytoin, oxcarbazepine, phenobarbital/ primidone,
CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of125 mg/m2

Subjects have newly diagnosed histologically proven supratentorial glioblastoma multiforme.
Toxicities associated w CPT-11 are anemia, decreased blood counts, diarrhea, constipation,
nausea, vomiting, tiredness, fever, mouth sores, dehydration, rash, itching, changes in skin
color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating, hot
flashes, hair loss, inflammation of liver, flu-like symptoms, decreased urine output,
shortness of breath,& pneumonia. Low white blood cell & platelet counts may be associated w
risk of infection/bleeding, respectively. Irinotecan has also caused birth defects in
animals. Most frequent toxicities in earlier studies have been low white blood cells &
diarrhea, & death has been seen from these & other side effects. Temozolomide has been well
tolerated by both adults & children w most common toxicity being mild myelosuppression.
Other, less likely, potential toxicities include nausea & vomiting, constipation, headache,
alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy,
hepatotoxicity, anorexia, fatigue & hyperglycemia. Hypersensitivity reactions have not yet
been noted w Temozolomide. As in case w many anti-cancer drugs, Temozolomide may be

Inclusion Criteria:

- Pts have histologically proven supratentorial GBM

- Pts have newly diagnosed disease

- There must be measurable disease on contrast-enhanced magnetic resonance imaging
performed <14 days before drug administration. Those who underwent resection must
have MRI <72 hrs/ >14 days after surgery

- Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts
must be treated <42 days of surgery or biopsy

- Age >18 yrs

- Karnofsky Performance Status >70 percent

- Serum creatinine < 1.5 x ULN

- Absolute neutrophil count >1500 cells/microliter; platelet count >100,000

- Serum SGOT & total bilirubin <2.5 x ULN

- Signed informed consent, approved by IRB, will be obtained prior to initiating

- Pts must agree to practice effective birth control measures while on study & for 2
months after completing therapy

Exclusion Criteria:

- Pregnant/breast feeding women / women/men w reproductive potential not practicing
adequate contraception. This therapy may be associated w potential toxicity to
fetus/child that exceeds minimum risks necessary to meet health needs of mother

- Active infection requiring intravenous antibiotics

- Known diagnosis of HIV infection

- Pts w history of another primary malignancy that currently requires active

- Pts unwilling/unable to comply w protocol due to serious medical/psychiatric

- Pts who underwent surgical resection for GBM <2 weeks of start of treatment

- Pts who have received prior chemo, biologic therapy, XRT, interstitial
brachytherapy/radiosurgery to brain

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

November 2005

Completion Date:

June 2009

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • GBM
  • Brain tumor
  • Temodar
  • Temozolomide
  • Irinotecan
  • CPT-11
  • Camptosar
  • Malignant glioma
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Glioblastoma
  • Glioma



Duke University Health SystemDurham, North Carolina  27705