Clinical trial · Interventional
CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
NCT00016328CI-TRIAL-00011414completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (temsirolimus)
- description
- 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.
- interventionNames
- Drug: temsirolimus
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Percentage of patients being progression free
- timeFrame
- 6 months
- description
- Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (5)
- measure
- Percentage of patients that have not progressed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.