Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide

NCT00616005

Last updated date
Study Location
Duke University Health System
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide
Official Title  ICMJE Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide
Brief Summary

Objective:

To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide

Detailed Description

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 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. 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 carcinogenic.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: Temodar and Irinotecan
Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle & every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-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 EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.
Other Names:
  • Temodar - Temozolomide
  • Irinotecan - Camptosar - CPT11
Study Arms  ICMJE
  • 1
    Pts taking EIAEDs
    Intervention: Drug: Temodar and Irinotecan
  • 2
    Pts not taking EIAEDs
    Intervention: Drug: Temodar and Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 13, 2008)
41
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00616005
Other Study ID Numbers  ICMJE Pro00012939
8044 ( Other Identifier: DUMC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:David A. Reardon, MDDuke University Health System
PRS Account Duke University
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP