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Oral Irinotecan + Temozolomide for Pediatric Solid Cancers
Study Summary
This trial is testing a flavored, orally-administered form of irinotecan (VAL-413) given with temozolomide to see if it is safe and effective for treating recurrent pediatric solid tumors, including neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT01055314Trial Design
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- My current cancer treatment options do not include a cure or significantly extend life with good quality.I don't need to have measurable disease to join this study.I am over 16 and can do most activities, or if under 16, I can do many activities without help.My kidney function is within the required range for my age and gender.I am not taking any medication that affects blood clotting, except for acetaminophen.I have not taken strong medication inducers like phenobarbital or St. John's Wort in the last 2 weeks.I am between 1 and 30 years old.My cancer was confirmed by a tissue test at diagnosis or relapse.I've had temozolomide, vincristine, or irinotecan without my cancer getting worse on them.My hemoglobin level is at least 8.0 gm/dL, even if I needed blood transfusions.My liver enzyme ALT levels are within 5 times the normal limit.My kidney function is within the normal range.I don't need to have measurable disease to join this study.My cancer was confirmed by a tissue test at diagnosis or relapse.My bilirubin levels are within the normal range for my age.I haven't taken any cancer drugs that lower blood counts in the last 7 days or 5 half-lives.I've had temozolomide, vincristine, or irinotecan without my cancer getting worse on them.My hemoglobin level is at least 8.0 gm/dL, even if I needed blood transfusions.I have recovered from the side effects of my previous cancer treatments.I am between 1 and 30 years old.It has been over 4 weeks since my last antibody therapy dose.My current cancer treatment options do not include a cure or significantly extend life with good quality.I have not taken strong CYP3A4 or UGT1A1 inhibitors in the last week.I do not have an uncontrolled infection or need IV antibiotics.I can care for myself but may not be able to do active work or play.My platelet count is above 100,000 and I haven't had a transfusion in the last week.I have never had a severe allergic reaction to dacarbazine or certain antibiotics.I agree to use effective birth control during and for 30 days after the study.
- Group 1: 75 mg/m2/day VAL-413 (Orotecan®)
- Group 2: 110 mg/m2/day VAL-413 (Orotecan®)
- Group 3: 90 mg/m2/day VAL-413 (Orotecan®)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any openings left in this research study for volunteers?
"The information on clinicaltrials.gov reveals that this clinical trial is currently recruiting volunteers for participation. The trial was initially posted on October 25th 2021 and recently updated the 11th of October 2022."
What have clinical studies revealed about the use of VAL-413 in patient care?
"VAL-413 is a known treatment for nitrosourea, as well as more complex diseases like refractory neuroblastoma, mycosis fungoides and advance directives."
Is this a pioneering medical experiment?
"Developed by Schering-Plough, the first study for VAL-413 was conducted in 2002 and involved 60 patients. After being approved for Phase 2 trials, 206 studies concerning this drug have been initiated across 36 countries and 935 cities."
Has VAL-413 been given the green light by the FDA?
"The tentative safety of VAL-413 has been assessed at a score of 1, as this is an early Phase 1 trial with little empirical evidence to support its efficacy and protection."
Are participants aged 45 or above eligible to join this trial?
"The age requirements for this clinical trial are between 1 Year and 30 Years old. There are 430 studies dedicated to participants under 18, and 996 trials specifically designed for persons over 65 years of age."
What is the scope of participation in this clinical investigation?
"Affirmative. The records stored on clinicaltrials.gov demonstrate that this trial, which was initially advertised on October 25th 2021 is recruiting individuals at the present time. Specifically, 20 patients need to be enrolled across 2 sites."
Who qualifies to join this clinical investigation?
"All participants in this clinical trial must have rhabdomyosarcoma and be between the age of one year old and thirty. There is a limit of 20 individuals who may partake in this study."
Are there any additional experiments that have been conducted on VAL-413?
"Currently, there are 206 VAL-413 clinical trials in live operation, with 23 of the studies having advanced to Phase 3. These clinical trial sites span across 4751 locations globally, with a prominent concentration situated around Seoul and Songpa."
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