Study on Dinutuximab, GM-CSF, Isotretinoin with Irinotecan and Temozolomide for High-Risk Neuroblastoma After Intensive Therapy
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT04385277
This clinical trial is testing a combination of treatments, including immunotherapy and chemotherapy, to see if they can be safely given to patients with high-risk neuroblastoma after intensive therapy. The goal is to find out if this combination can better treat the cancer compared to standard treatments.
Patient Parameters
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Program Overview
This study is exploring whether a combination of treatments, including dinutuximab (an immunotherapy), GM-CSF, isotretinoin, irinotecan, and temozolomide, can be safely administered to patients with high-risk neuroblastoma after they have completed intensive therapy. The aim is to see if this combination can improve treatment outcomes by targeting cancer cells more effectively without harming healthy cells. The study will also look at the safety of these treatments and how well they work in preventing the cancer from coming back or getting worse.
Description
The main goal of this study is to determine if a combination of dinutuximab, GM-CSF, and isotretinoin with irinotecan and temozolomide can be safely given to patients with high-risk neuroblastoma after they have completed intensive therapy, including stem cell transplants and radiation. Researchers will also look at the side effects of this treatment and how well it works in keeping the cancer from returning or worsening.
Patients will receive a series of treatments over several cycles, including oral and intravenous medications, and will undergo various scans and tests to monitor their health and the cancer's response to the treatment. The treatment cycles will repeat every 28 days for up to 5 cycles, with an additional cycle for isotretinoin if needed.
After completing the study treatment, patients will have follow-up visits at regular intervals to check on their health and monitor for any signs of cancer recurrence.
Eligibility Criteria
Inclusion Criteria
- Must be under 31 years old.
- Diagnosed with high-risk neuroblastoma or ganglioneuroblastoma.
- Completed intensive therapy, including chemotherapy and stem cell transplants.
- Have not experienced worsening or recurrence of the disease.
- Meet specific health criteria, including adequate blood counts and organ function.
- Must not have received certain treatments or medications recently.
- Must be able to provide informed consent and agree to follow study procedures.
Exclusion Criteria
- Have had disease progression since initial diagnosis, except in specific cases.
- Have received additional cancer treatments after completing intensive therapy.
- Have received certain types of radiation or other specific treatments.
- Are currently on other cancer therapies or immunosuppressive medications.
- Have certain health conditions or are taking medications that could interfere with the study.
- Are pregnant or breastfeeding, or not using effective contraception if of reproductive potential.
- Have a history of severe allergic reactions to similar treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| UCSF Medical Center-Mission Bay | 94158 | San Francisco | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | 80218 | Denver | Colorado |
| Connecticut Children's Medical Center | 06106 | Hartford | Connecticut |
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