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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00039468
First received: June 6, 2002
Last updated: October 26, 2011
Last verified: October 2011

June 6, 2002
October 26, 2011
March 2002
September 2007   (final data collection date for primary outcome measure)
Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00039468 on ClinicalTrials.gov Archive Site
Toxicity / QOL / Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.
Not Provided
Not Provided
Not Provided
 
Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: irinotecan hydrochloride
    350 or 700 mg/m2 IV every 3 weeks
    Other Name: CAMPTOSAR
  • Drug: thalidomide
    400mg/day oral
    Other Name: THALOMID
Not Provided
Fadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. Epub 2008 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2008
September 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme (GBM)

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

  • 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

Gastrointestinal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior thalidomide

Chemotherapy:

  • 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

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy for GBM

Surgery:

  • No prior surgical procedures affecting absorption

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00039468
D0134, DMS-15615, NCI-G02-2078
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Study Chair: Camilo E. Fadul, MD Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
October 2011

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