Adult Glioblastoma Clinical Trial
Official title:
A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | North Central Cancer Treatment Group | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients being progression free | Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner. | 6 months | No |
Secondary | Percentage of patients that have not progressed | Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner. | 3 months | No |
Secondary | Percentage of patients that have not progressed | Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner. | 12 months | No |
Secondary | Percentage of patients that have not progressed | Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner. | 18 months | No |
Secondary | Confirmed tumor response defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations | Ninety-five percent confidence intervals for the true proportion will be calculated using the exact binomial method. | Up to 10 years | No |
Secondary | Time to progression and death | Estimated using Kaplan-Meier. Frequency distributions of baseline patient characteristics will be compared using chi-squared and Wilcoxon tests. | Up to 10 years | No |
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