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Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting


OBJECTIVES:

- Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after
radiotherapy, in terms of time to tumor progression and overall survival, in patients
with newly diagnosed glioblastoma multiforme.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily
and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma

- Completed standard external beam radiotherapy within the past 5 weeks

- Stable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- More than 4 months

Hematopoietic

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- No history of bleeding disorder

Hepatic

- Bilirubin less than 1.5 mg/dL

- SGPT less than 2.5 times normal

- Alkaline phosphatase less than 2.5 times normal

Renal

- BUN less than 1.5 times upper limit of normal (ULN) OR

- Creatinine less than 1.5 times ULN

Cardiovascular

- No deep vein thrombosis within the past 3 weeks (must be clinically stable)

Pulmonary

- No pulmonary embolism within the past 3 weeks (must be clinically stable)

Other

- Must participate in System for Thalidomide Education and Prescribing Safety program

- No peripheral neuropathy grade 2 or greater

- No active infection

- No concurrent illness that may obscure toxicity or dangerously alter drug metabolism

- No other serious concurrent illness

- No other malignancy within the past 3 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception for 1 month before,
during, and for 1 month after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior thalidomide

- No concurrent immunotherapy

- No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy

- Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days

Radiotherapy

- See Disease Characteristics

- No concurrent radiotherapy

Surgery

- No concurrent surgery

Other

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Patrick Y. Wen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000257587

NCT ID:

NCT00047294

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult mixed glioma
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115