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A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme


I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are
progression-free at 6 months, time to progression, and time to death, in patients with
recurrent glioblastoma multiforme.

II. Determine the toxic effects of this drug in these patients. III. Correlate molecular
alterations in the tumors of these patients with response to treatment with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450
anticonvulsant use (yes vs no).

Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.

Inclusion Criteria:

- Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence

- Gliosarcoma allowed

- Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line

- Measurable or evaluable disease by MRI or CT scan

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal

- Creatinine no greater than 2.0 mg/dL

- No myocardial infarction within the past 6 months

- No congestive heart failure requiring ongoing maintenance therapy for
life-threatening ventricular arrhythmias

- Cholesterol no greater than 350 mg/dL

- Triglycerides no greater than 400 mg/dL

- Willing to provide correlative laboratory samples

- No uncontrolled infection

- No known hypersensitivity to any components of CCI-779, diphenhydramine
hydrochloride, or other similar antihistamines

- No other medical reason that would preclude diphenhydramine premedication

- No other active malignancy

- No other severe disease that would preclude study participation

- Not immunocompromised unless due to corticosteroids

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- See Disease Characteristics

- Prior adjuvant chemotherapy allowed

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No more than 1 prior chemotherapy regimen for recurrent/progressive disease

- No prior polifeprosan 20 with carmustine implant (Gliadel)

- Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week
prior to baseline scan

- See Disease Characteristics

- At least 12 weeks since prior radiotherapy

- No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a
separate lesion on MRI that is outside of the previously treated field

- No prior resection since last chemotherapy or radiotherapy unless there is
unequivocal tumor growth on neuro-imaging study since surgery or there is a separate
lesion not present in the surgical bed

- More than 4 weeks since prior investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Percentage of patients being progression free

Outcome Description:

Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Evanthia Galanis

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma



North Central Cancer Treatment Group Rochester, Minnesota  55905