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
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: irinotecan hydrochloride
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: March 2002
Study Completion Date: February 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039468

Locations
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
Investigators
Study Chair: Camilo E. Fadul, MD Norris Cotton Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00039468     History of Changes
Other Study ID Numbers: D0134, DMS-15615, NCI-G02-2078
Study First Received: June 6, 2002
Last Updated: October 26, 2011
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
adult glioblastoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Thalidomide
Irinotecan
Camptothecin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014