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Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas


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

Thank you

Trial Information

Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas


OBJECTIVES:

- Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in
terms of 6-month progression-free survival, in patients with relapsed or refractory
malignant glioma.

- Determine the overall survival of patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

- Determine the radiographic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42,
oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42.
Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with
anaplastic glioma) will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed intracranial malignant glioma, including glioblastoma
multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma,
anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified

- Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor
resection

- Steroid therapy prior to MRI or CT scan must have been at a stable dose for at
least 5 days

- Failed prior radiotherapy

- Must have confirmation of true progression rather than radiation necrosis
if previously treated with interstitial brachytherapy or stereotactic
radiosurgery

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- More than 2 months

Hematopoietic

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin greater than 9 g/dL

- 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

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

- BUN 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

- No peripheral neuropathy grade 2 or greater

- No active infection

- No other serious concurrent medical illness

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

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

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

- 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 oral thalidomide or celecoxib for more than 2 months duration

Chemotherapy

- No prior oral etoposide or cyclophosphamide for more than 2 months duration

- Prior standard-dose IV etoposide and cyclophosphamide allowed

Endocrine therapy

- See Disease Characteristics

- Concurrent steroids allowed

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

Surgery

- See Disease Characteristics

- Prior surgery for relapsed or refractory disease allowed

- Recovered from prior surgery

- No concurrent surgery

Other

- No other concurrent investigational agents or treatment

- No other concurrent anticancer therapy

- Concurrent antiseizure medications allowed

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:

CDR0000257584

NCT ID:

NCT00047281

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • adult mixed glioma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115