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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2002

Resources

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
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

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.

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