Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory… (NCT02800889) | Clinical Trial Compass
WithdrawnPhase 1
Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer
Stopped: Study withdrawn; no participants enrolled
United States0Started 2016-10-24
Plain-language summary
This is a phase 1, open-label, dose escalation study to evaluate the safety, pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed or refractory solid tumors (excluding those with CNS tumors) or lymphoma.
Who can participate
Age range
6 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
. Patient and/or guardian have signed an Informed Consent Form and Assent approved by the Institutional Review Board or Institutional Ethics Committee, as appropriate and necessary, on a per-age basis
. Age 6 months to 21 years old (initial qualifying diagnosis must have been made at or before the age of 18 and the patient must be under the care of a pediatric hematologist/oncologist)
. Patient received a diagnosis of lymphoma or any non-hematologic malignancy (except central nervous system \[CNS\] tumors) for which the patient is considered relapsed or refractory. (NOTE: CNS metastases are allowable in patients who are deemed not at risk for progression during the first 30 days, who are neurologically stable, and, if on corticosteroids, have been on a stable corticosteroid dose for at least 2 weeks.) Patients who have \>1 malignancy ongoing during screening are not eligible
. Patient must have one or more of the following treatment statuses:
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
MTD, defined as the highest dose level at which no more than 1/6 patients experience DLT
. In dose-escalation accrual, patients may have un-measurable disease (such as bone marrow/bone involvement or diffuse tumors)
. In dose-escalation accrual, patients may have un-measurable disease in cases where the standard of care would indicate the need for adjuvant chemotherapy after definitive surgery or radiation, but for whom no standard chemotherapy options are available
. In expansion cohort accrual, patients must have disease that is evaluable or measurable for response and progression per standard criteria for their diagnosis (Refer to the Appendices: RECIST 1.1 Criteria for Evaluation of Solid Tumors, Including Neuroblastoma, Appendix 18.4\], Evaluation of Neuroblastoma \[Appendix 18.6\], and the Lymphoma Staging and Disease Response Criteria \[Appendix 18.5\])
. Karnofsky-Lansky performance status (as per age of patient) ≥50 (Appendix 18.1)
Exclusion criteria
. Investigator-predicted life expectancy of less than two months
. Investigator-predicted inability to tolerate pixantrone monotherapy treatment adverse effects for less than two months
. Prior anthracycline treatment with a cumulative dose exceeding 450 mg/m2 (calculated based on doxorubicin equivalents)
. Active National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥grade 3 infection, or a lower grade infection deemed resistant or refractory to available antimicrobial agents, or infection requiring ongoing antibiotic treatment
. Major surgery ≤7 days and/or with incomplete/inadequate wound healing prior to start of study treatment
. Known acute or chronic hepatitis B or hepatitis C virus infection
. Known seropositivity for human immunodeficiency virus (HIV)
. Any experimental/investigational therapy ≤28 days prior to start of study treatment