MLN8237 to Treat Children With Relapsed/Refractory Solid Tumors (NCT02444884) | Clinical Trial Compass
CompletedPhase 1
MLN8237 to Treat Children With Relapsed/Refractory Solid Tumors
54 participantsStarted 2008-09
Plain-language summary
RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to see how well it works in treating young patients with relapsed or refractory solid tumors
Who can participate
Age range
12 Months – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis: Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of CSF or serum tumor markers including alpha-fetaprotein or beta-HCG.
* Performance Level: Karnofsky \>/= 50% for patients \> 16 years of age and Lansky
\>/= 50 for patients \</=16 years of age
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Adequate Bone Marrow Function Defined as:
a. For patients with solid tumors:
* Peripheral absolute neutrophil count (ANC) \>/= 1000/microLiter
* Platelet count \>/= 100,000/microLiter (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
* Hemoglobin \>/= 8.0 g/dL (may receive RBC transfusions)
* Creatinine clearance or radioisotope GFR \>/= 70ml/min/1.73 m2
* Bilirubin (sum of conjugated + unconjugated) \</= 1.5 x upper limit of normal (ULN) for age, and
* SGPT (ALT) \</= 5.0 x ULN for age (≤ 225 U/L). For the purpose of this study, the ULN for SGPT is 45 U/L.
* Serum albumin \>/= 2 g/dL.
Exclusion Criteria:
* Pregnant or breast-feeding women will not be entered on this study
* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine maximum tolerated dose and RP2D administered once daily on Days 1-7
Timeframe: Up to 21 days (1st cycle) of protocol therapy
2
Determine maximum tolerated dose and RP2D administered po BID on Days 1-7
Timeframe: Up to 21 days (1st cycle) of protocol therapy
3
Adverse events as assessed by (CTCAE) version 4.0
Timeframe: Every 21 days (each cycle) of protocol therapy for up to 35 cycles [up to 105 weeks]
4
PK Profile: MLN8237 concentrations in plasma samples
Timeframe: 30 min after the first dose, and at 1,2, 3, 4, 6-8, 24 hours, Day 4 and 7 in Cycle 1