Lenalidomide in Treating Young Patients With Recurrent, Progressive, or Refractory CNS Tumors (NCT00100880) | Clinical Trial Compass
CompletedPhase 1
Lenalidomide in Treating Young Patients With Recurrent, Progressive, or Refractory CNS Tumors
United States45 participantsStarted 2004-11
Plain-language 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. It may also stimulate the immune system in different ways and stop tumor cells from growing.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 registrati…
What they're measuring
1
MTD, estimated using the modified Continual Reassessment Method (CRM)