CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
erlotinib +4 moredrug
Likely dose
Erlotinib administered orally; temsirolimus administered IV (specific doses not stated in published record)AI-extracted
Key inclusion· 9
  • ✓Histologically proven intracranial malignant glioma including GBM, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma NOS; eligible if original histology was low-grade with subsequent malignant diagnosis
  • ✓Unequivocal evidence of tumor progression by MRI or CT within 14 days prior to registration
  • ✓Prior failed radiation therapy with ≥6 weeks interval from completion to study entry
  • ✓For prior brachytherapy or stereotactic radiosurgery: confirmation of true progressive disease vs. radiation necrosis by PET, Thallium scanning, MR spectroscopy, or surgical documentation
Key exclusion· 7
  • ✕Prior therapy with temsirolimus, erlotinib, or other mTOR or EGFR inhibitors
  • ✕On enzyme-inducing anti-epileptic drug (EIAED); if previously on EIAED, must be off for ≥2 weeks prior to registration
  • ✕Any other active cancer (except non-melanoma skin cancer or cervical carcinoma in-situ), unless in complete remission and off therapy for ≥3 years
  • ✕Active infection or serious intercurrent medical illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112736
NCT00112736Phase 2Completed
CompareCT.gov

Phase I/II Study of OSI-774 (Erlotinib) and CCI-779 (Temsirolimus) in Patients With Recurrent Malignant Glioma

National Cancer Institute (NCI)·interventional·Posted Jun 3, 2005·Updated Jun 15, 2015

In Brief

A Phase 2 clinical trial evaluating erlotinib, temsirolimus, and 3 other interventions for Adult Anaplastic Astrocytoma and 10 related conditions. Completed, enrolled 69 participants across 8 sites.

Detailed Summary

Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with erlotinib and to see how well they work in treating patients with recurrent malignant glioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Recurrent Adult Brain Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2005
Enrollment StartApr 1, 2005
Primary CompletionApr 1, 2010
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 21.1 years ago

Interventions

erlotinibdrug

Given orally

temsirolimusdrug

Given IV

therapeutic conventional surgeryprocedure

Undergo surgical resection

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies