Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temo
Information source: Duke University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioblastoma
Intervention: Temodar and Irinotecan (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Jennifer Quinn, MD, Principal Investigator, Affiliation: Duke University Health System
Summary
Objective:
To determine activity of combo of Irinotecan + Temozolomide To further characterize any
toxicity associated w combo of Irinotecan + Temozolomide
Clinical Details
Official title: Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Progression-free survival
Secondary outcome: Toxicity assessment
Detailed description:
Objectives of study are to determine activity of combo of Irinotecan + Temo & to further
characterize any toxicity associated w combo of Irinotecan + Temo. Temo administered orally
at 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temo 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 Temo
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 administered.
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. Temo 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 Temo.
As in case w many anti-cancer drugs, Temo may be carcinogenic.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
cells/microliter
- Serum SGOT & total bilirubin <2. 5 x ULN
- Signed informed consent, approved by IRB, will be obtained prior to initiating
treatment
- 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
intervention
- Pts unwilling/unable to comply w protocol due to serious medical/psychiatric
condition
- 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
Locations and Contacts
Duke University Health System, Durham, North Carolina 27710, United States
Additional Information
The Preston Robert Tisch Brain Tumor Center at DUKE
Starting date: November 2005
Ending date: January 2010
Last updated: February 13, 2008
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