Clinical trial · Interventional
Sirolimus in Treating Patients With Glioblastoma Multiforme
A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme
NCT00047073CI-TRIAL-00046383completedPhase 1 / Phase 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)
RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin | Drug | Sirolimus | ALIAS |
| Supportive Care | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1
- description
- See intervention description.
- interventionNames
- Drug: Rapamycin
- Procedure: Surgery
- Procedure: Supportive Care
- type
- EXPERIMENTAL
- label
- Phase 2
- description
- See intervention description.
- interventionNames
- Drug: Rapamycin
- Procedure: Surgery
- Procedure: Supportive Care
Primary outcomes (2)
- measure
- Maximum tolerated dose (for phase 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed intracranial glioblastoma multiforme
* Disease progression by MRI or CT scan
* Confirmation of true progressive disease (not radiation necrosis) by positron-emission tomography, thallium scanning, MRI, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery
* Failed prior radiotherapy
* Phase I patients:
* Eligible for salvage surgery
* No limits on prior therapy
* Phase II patients:
* Tumor progression by MRI or CT scan required within the past 14 days if recurrent disease is present
* No prior therapy for more than 3 relapses
* Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply:
* Recovered from surgery
* MRI or CT scan performed no more than 96 hours since prior surgery OR within 4-6 weeks after surgery
* Baseline MRI or CT scan performed within 14 days of study entry
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* More than 8 weeks
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT less than 1.5 times ULN
Renal
* Creatinine less than 1.5 mg/dL
Other
* Cholesterol less than 350 mg/dL
* Triglycerides less than 400 mg/dL
* No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
* No other significant uncontrolled serious medical illness that would preclude study participation
* No other cancer except non-melanoma skin cancer or carcinoma in situ of the cervix unless patient is in complete remission and off all therapy for that disease for at least 3 years
* No active infection
* No prior allergic reactions to compounds of similar chemical or biological composition to sirolimus
* No psychiatric illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 1 week since prior interferon
Chemotherapy
* At least 2 weeks since prior vincristine
* At least 3 weeks since prior procarbazine
* At least 6 weeks since prior nitrosoureas
Endocrine therapy
* At least 1 week since prior tamoxifen
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
Surgery
* See Disease Characteristics
Other
* Recovered from prior therapy
* At least 1 week since prior noncytotoxic agents (except radiosensitizers)References
Publications (1)
- RESULTCloughesy TF, Yoshimoto K, Nghiemphu P, Brown K, Dang J, Zhu S, Hsueh T, Chen Y, Wang W, Youngkin D, Liau L, Martin N, Becker D, Bergsneider M, Lai A, Green R, Oglesby T, Koleto M, Trent J, Horvath S, Mischel PS, Mellinghoff IK, Sawyers CL. Antitumor activity of rapamycin in a Phase I trial for patients with recurrent PTEN-deficient glioblastoma. PLoS Med. 2008 Jan 22;5(1):e8. doi: 10.1371/journal.pmed.0050008. PMID 18215105