Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors (NCT01282697) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
France42 participantsStarted 2011-04-22
Plain-language summary
Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs.
Who can participate
Age range
1 Year – 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:
* Age \>= 1 year old and =\< 21 years old;
* Refractory solid tumors, histologically proven at diagnosis (no additional biopsy needs to be performed for the purpose of the study);
* Relapsed or refractory solid tumors after standard treatment or phase II, III-IV clinical trials treatment have failed;
* Karnofsky or Lansky status \>= 70%;
* Life expectancy \>= 8 weeks;
* No chemotherapy / radiotherapy within 4 weeks before entry into the study;
* Adequate biological parameters :
* Absolute neutrophil count \>= 1.0 x 109/L;
* Platelet count \>= 100 x 109/L;
* Hemoglobin \>= 8 mg/dL;
* Total bilirubine =\< 1.5 ULN;
* Transaminases =\< 2.5 ULN (=\< 5 ULN in case of liver metastases);
* Creatinine clearance (Cockroft) \>= 70 mL/min/1.73 m2;
* Normal coagulation profile with prothrombin \>= 70%, TCA =\< 35 and fibrinogen \>= 2 g/L;
* Patients with 1 to 3 previous therapeutic lines are eligible;
* No current grade \>= 2 organ toxicity based on NCI-CTCAE version 3.0;
* All patients with reproductive potential must have an effective method of birth control while on study;
* Negative pregnancy test in females when indicated;
* Informed written consent signed by patients or their parents or legal guardians;
* Patient who was informed of the results of prior medical consultation;
* Patient having a social insurance.
Exclusion Criteria:
* Patient with a constitutional anomaly of coagulation and/or of hemostasis (type hemophilia, von Willebrand disease…
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 the maximum tolerated dose (MTD) of irinotecan and rapamycin combination in children with refractory solid tumors.
Timeframe: 28 days
2
Characterize the pharmacokinetics of rapamycin and irinotecan during the first cycle of treatment.