Clinical trial · Interventional
CC-5013 in Treating Patients With Recurrent Glioma
A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
NCT00036894CI-TRIAL-00017740completedPhase 1ClinicalTrials.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: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following:
* Histologically confirmed high-grade glioma
* Glioblastoma multiforme
* Gliosarcoma
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Malignant glioma/astrocytoma, not otherwise specified
* Meningioma
* Hemangioblastoma
* Ependymoma
* Primitive neuroectodermal tumors
* Hemangiopericytoma
* Progressive glioma
* Clinically and radiographically diagnosed brain stem glioma
* Progressive or recurrent disease as determined by CT scan or MRI
* Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor
* Must have failed prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* WBC at least 2,300/mm\^3
* Platelet count at least 90,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusions allowed)
Hepatic:
* Bilirubin less than 3 times upper limit of normal (ULN)
* SGOT less than 3 times ULN
* No significant active hepatic disease
Renal:
* Creatinine less than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No significant active renal disease
Cardiovascular:
* No significant active cardiac disease
Other:
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No significant active psychiatric disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 2 weeks since prior interferon
* No concurrent immunotherapy
Chemotherapy:
* At least 6 weeks since prior nitrosoureas
* At least 4 weeks since prior temozolomide or carboplatin
* At least 3 weeks since prior procarbazine
* At least 2 weeks since prior vincristine
* At least 4 weeks since other prior cytotoxic chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* At least 2 weeks since prior tamoxifen
* Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days
Radiotherapy:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior tumor resection
Other:
* At least 2 weeks since other prior noncytotoxic agents
* Concurrent enzyme-inducing antiepileptic drugs allowed
* No concurrent rifampin
* No concurrent grapefruit juice
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTFine HA, Kim L, Albert PS, Duic JP, Ma H, Zhang W, Tohnya T, Figg WD, Royce C. A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors. Clin Cancer Res. 2007 Dec 1;13(23):7101-6. doi: 10.1158/1078-0432.CCR-07-1546. PMID 18056189