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Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with
recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II.
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 daily on days 1-28. Treatment repeats every 28 days for a maximum
of 24 courses in the absence of disease progression or unacceptable toxicity. Patients are
followed at 1 month and then for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme
or gliosarcoma Must have evidence of tumor recurrence or progression by MRI scan after
failing prior radiotherapy Bidimensionally measurable enhancing residual disease on MRI or
CT scan Prior recent resection of recurrent or progressive tumor allowed if all of the
following conditions apply: Recovered from surgery Residual evaluable disease present that
is not artifactual postsurgical enhancement Baseline MRI or CT scan is performed within 14
days prior to study and while on a steroid dose that has been stable for at least 5-7 days

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times normal Alkaline
phosphatase less than 2 times normal Bilirubin less than 1.5 mg/dL Renal: BUN or
creatinine less than 1.5 times normal Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use one highly effective method of contraception, AND one
additional effective method of contraception for at least 4 weeks before, during, and for
8 weeks after study No peripheral neuropathy greater than grade 1 No active infection No
other illness that would obscure toxicity or alter drug metabolism No other concurrent
serious medical illness No other prior cancer within the past 3 years except nonmelanoma
skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide No other concurrent
biologic therapy for cancer Chemotherapy: No more than 1 prior chemotherapy regimen At
least 3 weeks since prior chemotherapy (2 weeks for vincristine and 6 weeks for
nitrosoureas) No other concurrent chemotherapy for cancer Endocrine therapy: See Disease
Characteristics No concurrent endocrine therapy for cancer Radiotherapy: See Disease
Characteristics No concurrent radiotherapy for cancer Surgery: See Disease Characteristics
No concurrent surgery for cancer Other: Recovered from prior therapy No other concurrent
investigational drugs for cancer

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Morris D. Groves, MD, JD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

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



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University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Neuro-Oncology Branch Bethesda, Maryland  20892