Pomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nerv… (NCT02415153) | Clinical Trial Compass
CompletedPhase 1
Pomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
United States29 participantsStarted 2015-07-14
Plain-language summary
This phase I trial studies the side effects and best dose of pomalidomide in treating younger patients with tumors of the brain or spine (central nervous system) that have come back or are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow and spread and may also stimulate the immune system to kill tumor cells.
Who can participate
Age range3 Years – 20 Years
SexALL
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Inclusion Criteria:
* Patients must have received standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy
* Patients with a histologically confirmed diagnosis of a primary CNS tumor that is recurrent, progressive or refractory to standard therapy; refractory disease will be defined as the presence of persistent abnormality on conventional magnetic resonance imaging (MRI) imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment; all tumors must have histological verification at either the time of diagnosis or recurrence except for patients with diffuse intrinsic brain stem tumors or optic pathway gliomas; patients with neurofibromatosis type-I (NF-1) associated CNS tumors are eligible if they meet all other eligibility criteria
* Patients must have evaluable disease on MRI imaging
* Patients must have body surface area (BSA) \> 0.55 m\^2 at the time of enrollment
* In the event of de-escalation from dose level 1 to dose level 0, patients with BSAs \< 0.67 m\^2 are not eligible
* Patients must have recovered from clinically significant, acute, treatment-related toxicities of prior therapies; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =\< 2, using Common Terminology Criteria for Adverse Events (CTCAE) v…
What they're measuring
1
Maximum tolerated dose/recommended phase II dose of pomalidomide
Timeframe: Up to 28 days
2
Pharmacokinetics parameters of pomalidomide
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose day 1 of course 1; 1 sample pre-dose any day between days 3-21 of course 1