CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016328
First received: May 6, 2001
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor |
Drug: temsirolimus Other: laboratory biomarker analysis Other: pharmacological study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Percentage of patients being progression free [ Time Frame: 6 months ] [ Designated as safety issue: No ]Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
Secondary Outcome Measures:
- Percentage of patients that have not progressed [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
- Percentage of patients that have not progressed [ Time Frame: 12 months ] [ Designated as safety issue: No ]Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
- Percentage of patients that have not progressed [ Time Frame: 18 months ] [ Designated as safety issue: No ]Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
- Confirmed tumor response defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Ninety-five percent confidence intervals for the true proportion will be calculated using the exact binomial method.
- Time to progression and death [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier. Frequency distributions of baseline patient characteristics will be compared using chi-squared and Wilcoxon tests.
| Enrollment: | 33 |
| Study Start Date: | May 2001 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: temsirolimus
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016328
Locations
| United States, Minnesota | |
| North Central Cancer Treatment Group | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Evanthia Galanis | North Central Cancer Treatment Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016328 History of Changes |
| Other Study ID Numbers: | NCI-2012-01858, N997B, U10CA025224, CDR0000068623 |
| Study First Received: | May 6, 2001 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Gliosarcoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013