CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

NCT ID: NCT00016328

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31

Brief Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description

OBJECTIVES:

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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (temsirolimus)

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.

Group Type: EXPERIMENTAL

temsirolimus

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

temsirolimus

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CCI-779; cell cycle inhibitor 779; Torisel; pharmacological studies

Eligibility Criteria

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 chemotherapy
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evanthia Galanis

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

North Central Cancer Treatment Group

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

N997B

Identifier Type: -

Identifier Source: secondary_id

CDR0000068623

Identifier Type: -

Identifier Source: secondary_id

NCCTG-N997B

Identifier Type: -

Identifier Source: secondary_id

U10CA025224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01858

Identifier Type: -

Identifier Source: org_study_id