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A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Camilo E. Fadul, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

D0134

NCT ID:

NCT00039468

Start Date:

March 2002

Completion Date:

February 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240