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Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039468
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 27, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: irinotecan hydrochloride Drug: thalidomide Phase 2

Detailed Description:


  • Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
  • Determine the preliminary efficacy of this regimen in these patients.
  • Determine the disease-free survival and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
Study Start Date : March 2002
Actual Primary Completion Date : September 2007
Actual Study Completion Date : February 2008

Intervention Details:
  • Drug: irinotecan hydrochloride
    350 or 700 mg/m2 IV every 3 weeks
    Other Name: CAMPTOSAR
  • Drug: thalidomide
    400mg/day oral
    Other Name: THALOMID

Primary Outcome Measures :
  1. Response [ Time Frame: 2 years ]
    To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.

Secondary Outcome Measures :
  1. Toxicity / QOL / Survival [ Time Frame: 2 years ]
    To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed glioblastoma multiforme (GBM)

    • Recurrent disease allowed
  • Evaluable disease on contrast-enhanced MRI
  • Prior external beam radiotherapy required



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 5 times ULN


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No significant cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure
  • No myocardial infarction within the past 3 months
  • No serious cardiac arrhythmias


  • Able to take oral medication
  • No gastrointestinal abnormalities
  • No requirement for IV alimentation
  • No active peptic ulcer disease


  • No active infection
  • No serious uncontrolled medical disorder
  • No dementia or significantly altered mental status that would preclude study
  • No known hypersensitivity to irinotecan or thalidomide
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study


Biologic therapy:

  • No prior thalidomide


  • No prior irinotecan
  • At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse)

Endocrine therapy:

  • Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study
  • No concurrent hormonal therapy for GBM


  • See Disease Characteristics
  • No concurrent radiotherapy for GBM


  • No prior surgical procedures affecting absorption


  • No other concurrent anticancer investigational agents for GBM
  • No concurrent cytochrome P450 inhibitors, including the following:

    • Nefazodone
    • Fluvoxamine
    • Fluoxetine
    • Sertraline
    • Paroxetine
    • Venlafaxine
    • Ketoconazole
    • Itraconazole
    • Fluconazole
    • Cimetadine
    • Clarithromycin
    • Diltiazem
    • Erythromycin
    • Protease inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039468

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United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
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Study Chair: Camilo E. Fadul, MD Norris Cotton Cancer Center
Publications of Results:
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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00039468    
Other Study ID Numbers: D0134
DMS-15615 ( Other Identifier: Dartmouth-Hitchcock Medical Center )
NCI-G02-2078 ( Other Grant/Funding Number: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011
Keywords provided by Dartmouth-Hitchcock Medical Center:
adult glioblastoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances