Brain and Central Nervous System TumorsPhase 1NCT00036894
CC-5013 in Treating Patients With Recurrent Glioma
A Phase 1 study testing lenalidomide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- lenalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
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.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antiangiogenic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- lenalidomide
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult ependymoblastoma, adult anaplastic ependymoma, adult myxopapillary ependymoma, adult meningioma, adult meningeal hemangiopericytoma, adult brain stem glioma, adult grade III meningioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Neuroectodermal Tumors, Primitive, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Howard A. Fine, MD, Study chair, NCI - Neuro-Oncology Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036894
- Sponsor's protocol ID
- CDR0000069338
- Other IDs
- NCI-02-C-0145
- Status last verified
- Nov 2003
- First submitted
- 13 May 2002
- Last updated
- 30 Apr 2015
- Results posted
- No
Publications
Fine 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.
PubMed 18056189
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00036894
- Acronym / sponsor ID
- CDR0000069338
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult ependymoblastoma, adult anaplastic ependymoma, adult myxopapillary ependymoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2002
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antiangiogenic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Results publication: PubMed 18056189Fine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard A. Fine, MD study chair
NCI - Neuro-Oncology Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00036894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.