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

NCT ID: NCT00039468

Last Updated: 2011-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2008-02-29

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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

irinotecan hydrochloride

350 or 700 mg/m2 IV every 3 weeks

Intervention Type: DRUG

thalidomide

400mg/day oral

Intervention Type: DRUG

Other Intervention Names

CAMPTOSAR; THALOMID

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilo E. Fadul, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26.

Reference Type: RESULT

PMID: 18661102 (View on PubMed)

Other Identifiers

DMS-15615

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G02-2078

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D0134

Identifier Type: -

Identifier Source: org_study_id