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Chemotherapy for Recurrent Solid Cancers in Children
Study Summary
This trial is testing the side effects and best dose of a drug called nanoparticle albumin-bound rapamycin when given with two other chemotherapy drugs, temozolomide and irinotecan hydrochloride, in treating pediatric patients with solid tumors that have come back or stopped responding to treatment.
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 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358Trial Design
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Who is running the clinical trial?
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- My nerve-related side effects from previous treatments are mild.My condition cannot be cured with current treatments.I have waited the required time after my last therapy before joining this trial.I am on corticosteroids and meet the specific requirements.I am taking medication that affects how my body processes drugs.I have a history of severe depression.My neurological symptoms have been stable for at least a week.I am mostly able to care for myself, regardless of my age.I have interstitial lung disease or pneumonitis.I have a current or recent history of deep vein thrombosis.I do not have any infections that are currently uncontrolled.My cancer has come back or didn’t respond to treatment, and it was confirmed by tests.My cancer can be measured or seen on tests.I have recovered from side effects of previous cancer treatments.I have had or am planning to have a surgery or procedure.I am currently on blood thinners for treatment.My lab tests and health check-ups meet the required standards.My cancer has spread to my bone marrow.My seizures are well controlled with specific medication.My bone marrow is functioning well.My cancer tissue samples will be sent for the study, or the study chair will be informed if not possible.I am taking medication after a bone marrow transplant.I have taken seizure medication that affects enzyme levels recently.
- Group 1: Treatment (nab-rapamycin, temozolomide, irinotecan)
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What is the upper bound of individuals participating in this trial?
"This clinical trial has ceased taking in new participants. It was initially posted on July 24th 2017 and last updated on the 25th of July 2022. If you are looking for additional studies, there currently exist 3363 cancer-related trials that are recruiting patients and 686 Pharmacological Studies actively enrolling volunteers."
How many centers are managing the clinical trial?
"As of now, 21 medical sites are accepting patients for this trial. Examples include Lurie Children's Hospital-Chicago in Chicago, Children's Hospital of Orange County in Orange and Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center located in Houston. Additionally, there are 18 other centres participating in the recruitment process."
Is there currently an opportunity to join the trial?
"This trial has since concluded its recruitment phase; it was first posted on July 24th 2017 and the last edit occured on July 25th 2022. However, there are still 3363 clinical trials accepting cancer patients as participants and 686 more for those interested in Pharmacological Studies."
Am I eligible to partake in this research project?
"This medical trial is recruiting 33 patients with cancer aged between 12 Months and 21. Those interested must meet the following criteria: have a malignancy without known curative therapy, possess a body surface area (BSA) of 0.2 m^2 or greater at time of enrollment, exhibit measurable/evaluable disease signs, Karnofsky >= 50% for individuals 16+ in age & Lansky >=50 for those below that milestone; stable neurological deficits if applicable, & full recovery from prior anti-cancer treatments including cytotoxic chemotherapy within 21 days (42 where nitrosourea was used); all other forms of anti-"
Has the Pharmacological Study gained regulatory approval from the FDA?
"The limited clinical data for this pharmacological study resulted in a safety rating of 1."
Is the age threshold for enrolment in this research higher than seventy-five years?
"According to the parameters of this trial, candidates aged between 12 months and 21 years old are eligible for enrollment."
What maladies can be addressed via Pharmacological Study?
"Pharmacological Study has been known to provide successful treatment for neoplastic metastases, mediastinitis and small cell lung cancer (SCLC)."
Are there any precedented clinical investigations of Pharmacological Study?
"Presently, 106 Phase 3 clinical research studies are being conducted on Pharmacological Study. Most of the trials are located in Woolloongabba, Queensland but there exist 16515 sites that host these experiments."
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