Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma (NCT01273090) | Clinical Trial Compass
CompletedPhase 1
Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma
United States34 participantsStarted 2011-05
Plain-language summary
RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I clinical trial is studying the side effects and best dose of imetelstat sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.
Who can participate
Age range1 Year – 21 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.
DISEASE CHARACTERISTICS:
* Diagnosis of refractory or recurrent solid tumors, including lymphoma
* No CNS tumors or known CNS metastases (Part A, dose escalation)
* CNS tumors or known CNS metastases allowed (Part B, maximum-tolerated dose or recommended phase II dose)
* No prior or concurrent CNS hemorrhage on a baseline MRI within the past 14 days
* All patients must have histologic verification of malignancy at original diagnosis or relapse except for:
* Intrinsic brain stem tumors
* Optic pathway gliomas
* Pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG
* Measurable or evaluable disease
* Disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood count criteria and they are not known to be refractory to red cell or platelet transfusions
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (patients \> 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years of age)
* ANC ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³ (transfusion-independent, defined as not receiving platelet transfusion within the past 7 days prior to enrollment)
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age and/or gender as follows:
* 0.6 mg/dL (1 to \< 2 years of age)
* 0.8 mg/dL (2 to \< 6…
What they're measuring
1
Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma