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AzTrials

Childhood Atypical Teratoid/Rhabdoid TumorPhase 1NCT00100880

Lenalidomide in Treating Young Patients With Recurrent, Progressive, or Refractory CNS Tumors

A Phase 1 study testing lenalidomide, perfusion-weighted magnetic resonance imaging and diffusion-weighted magnetic resonance imaging in people with Childhood Atypical Teratoid/Rhabdoid Tumor and Childhood Central Nervous System Germ Cell Tumor, 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

This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with recurrent, progressive, or refractory CNS tumors. Lenalidomide may stop the growth of CNS tumors by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
lenalidomide, perfusion-weighted magnetic resonance imaging and diffusion-weighted magnetic resonance imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Nov 2004to Nov 2010
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with a histological diagnosis of a primary CNS tumor (including histologically benign brain tumors (e.g. low-grade glioma) that is recurrent, progressive, or refractory to standard therapy; patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation of disease but should have clinical and/or radiographic evidence of progression
  • Karnofsky Performance Scale (KPS for >= 16 yrs of age) or Lansky Performance Score (LPS for ≤ 16 years of age) ≥ 60 assessed within two weeks prior to registration
  • Patient must be able to swallow capsules
  • Patients must have recovered from any significant acute toxicity associated with prior therapy; patients must have no known curative therapy available; patients will be eligible regardless of the number of prior therapies, as long as other eligibility criteria are met
  • Chemo: Prior use of thalidomide is acceptable; patients must have:
  • Received their last dose of known myelosuppressive anticancer chemotherapy or biological therapy at least three (3) weeks prior to study registration
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  • Received their last dose of nitrosourea or mitomycin-C at least six (6) weeks prior to study registration
  • Received their last dose of other investigational agent or an anticancer drug known to not be myelosuppressive at least seven (7) days prior to study registration
  • XRT: Patients must have had their last fraction of craniospinal irradiation ≥ 3 months prior to registration and their last fraction of local irradiation to primary tumor ≥ 4 weeks prior to registration
  • Bone Marrow Transplant: ≥ 6 months since allogeneic bone marrow transplant and ≥ 3 months since autologous bone marrow/stem cell prior to registration
  • Growth factors: Off all colony forming growth factor(s) > 2 weeks prior to registration (filgrastim, sargramostim, erythropoietin)
  • The following laboratory values must be assessed within two (2) weeks prior to registration and again within seven (7) days prior to the start of therapy; laboratory tests should be repeated within 48 hours of beginning therapy if there has been a significant clinical change
  • Absolute neutrophil count ≥ 1000/μl (unsupported)
  • Platelets ≥ 100,000/μl (unsupported)
  • Hemoglobin ≥ 8.0 g/dL (may be supported)
  • Serum creatinine within upper limit of institutional normal for age
  • Or GFR ≥ 70 ml/min/1.73m^2
  • Bilirubin ≤ 1.5 times upper limit of normal for age
  • SGPT (ALT) ≤ 2.5x institutional upper limit of normal for age
  • Albumin ≥ 2 g/dL
  • No overt renal, hepatic, cardiac or pulmonary disease
  • Female patients of childbearing potential must have negative serum or urine pregnancy test (sensitivity of at least 50mIU/ml); patients must not be pregnant or breast-feeding
  • All sexually active females must begin 2 methods of birth control, including 1 highly effective method, and 1 additional method (at the same time) at least 4 weeks prior to the first dose of CC-5013; this applies to all sexually active females of childbearing potential unless they have not had a menstrual period in 2 years or have undergone a hysterectomy
  • Patients of child fathering potential must agree to use latex condoms during intercourse with a woman while taking CC-5013 and for 4 weeks thereafter
  • Signed informed consent according to institutional guidelines must be obtained

Who cannot join

  • Patients with a body surface area (BSA) ≤ 0.4 m^2 are excluded
  • Patients with a first-degree relative with a history of venous thrombosis before age 50 yrs or an arterial thrombosis before age 40 yrs are excluded
  • Patients who have had a thromboembolic event that is not line-related are excluded
  • Patients with any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise a patient's ability to tolerate this therapy
  • Patients with any disease that would obscure toxicity or dangerously alter drug metabolism
  • Patients receiving any other chemotherapeutics or investigational agents
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  • Patients with uncontrolled infection
  • Patients unable to swallow capsules
  • Patients with known hypersensitivity to anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pediatric Brain Tumor Consortium

    Memphis, Tennessee, 38105

Other trials in United States

About this study

Official title: A Phase I Trial of CC-5013 (Lenalidomide) in Pediatric Patients With Recurrent or Refractory Primary CNS Tumors

This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with recurrent, progressive, or refractory CNS tumors. Lenalidomide may stop the growth of CNS tumors by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the MTD of oral CC-5013 administered to children with recurrent or refractory primary CNS tumors once daily for 21 days of a 28 day course.

II. To describe the toxicity profile and define the dose-limiting toxicity of CC-5013 in children with recurrent or refractory primary CNS tumors.

SECONDARY OBJECTIVES:

  1. To characterize the pharmacokinetics of CC-5013 in children and adolescents. II. To characterize the pharmacogenetics of CC-5013 in children and adolescents.

III. To evaluate changes in circulating endothelial cells (CECs) and circulating endothelial cell precursors (CEPs) in patients treated with CC-5013, and to investigate the correlation between changes in CECs and CEPs, plasma, serum and urine levels of proteins associated with angiogenesis including thrombospondin, b-FGF, TNF-α, IL-12, IL-8 and VEGF, and correlate these changes with changes in MR perfusion and clinical outcome.

IV. To evaluate changes in MR perfusion and diffusion during treatment.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 2-3 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which an estimated 25% of patients experience dose-limiting toxicity.

All patients are followed for at least 30 days after the last dose of lenalidomide. Patients with treatment-related toxicity are followed for up to 3 months.

Being tested
lenalidomide, perfusion-weighted magnetic resonance imaging, diffusion-weighted magnetic resonance imaging, laboratory biomarker analysis
Medical subject headings
Rhabdoid Tumor, Choroid Plexus Neoplasms, Astrocytoma, Oligodendroglioma, Familial ependymoma, Medulloblastoma, Optic Nerve Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • perfusion-weighted magnetic resonance imagingProcedure or surgery

    Also called PW-MRI

    Correlative studies

  • diffusion-weighted magnetic resonance imagingProcedure or surgery

    Also called diffusion-weighted MRI

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00100880
Study groupRoleWhat they receive
Treatment (lenalidomide)ExperimentalPatients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 2-3 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which an estimated 25% of patients experience dose-limiting toxicity.
Receives: Drug: lenalidomide; Procedure: perfusion-weighted magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD, estimated using the modified Continual Reassessment Method (CRM)

    Measured: 28 days

Secondary outcomes (1)

  1. Plasma drug concentrations and pharmacokinetic parameters, including volume of the central compartment (Vc/F), elimination rate constant (Ke), half-life (t1/2), apparent oral clearance (CL/F), and area under the plasma concentration time curve (AUC)

    Presented in tabular and graphical form and determined using compartmental methods. Dose proportionality in pharmacokinetic parameters will be determined by performing one-way analysis of variance (ANOVA) on dose-normalized parameters.

    Measured: Baseline and course 1

Timeline

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

  1. First posted7 Jan 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionNov 2010

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100880
Sponsor's protocol ID
NCI-2012-03176
Other IDs
NCI-2012-03176, CDR653734, PBTC-018, PBTC-018, U01CA081457
Status last verified
Sep 2013
First submitted
6 Jan 2005
Last updated
30 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide, perfusion-weighted magnetic resonance imaging and diffusion-weighted magnetic resonance imaging in people with Childhood Atypical Teratoid/Rhabdoid Tumor and Childhood Central Nervous System Germ Cell Tumor, 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?

The sponsor lists 25 inclusion and 9 exclusion criteria. 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 Sep 2013. 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.

What does the primary outcome measure?

MTD, estimated using the modified Continual Reassessment Method (CRM) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00100880.

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 Sep 2013; AzTrials last refreshed its copy on 1 Nov 2026.

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