Study on Durvalumab and Tremelimumab for Children with Advanced Cancers
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03837899
This clinical trial is testing the safety and appropriate dosage of two immunotherapy drugs, durvalumab and tremelimumab, in children with advanced solid and blood cancers. The study will also explore how effective these drugs are once the right dose is found.
Patient Parameters
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Program Overview
The aim of this study is to find the best dose of two immunotherapy drugs, durvalumab and tremelimumab, for children with advanced solid tumors and blood cancers, such as lymphomas, who have no other treatment options. The study will first focus on ensuring the drugs are safe and well-tolerated. Once the right dose is determined, the study will expand to see how well these drugs work in treating the cancers.
Description
This is the first study to test durvalumab and tremelimumab in children with advanced cancers. The main goal is to see if these drugs are safe and to find the best dose for children with solid tumors and blood cancers, like lymphomas, who have no other treatment options. Although the study's main focus is not on how well the drugs work, it offers hope for some benefit to children who have no other curative options.
The study will also look at how the body processes these drugs and their potential effects on the immune system and cancer cells. The results will help decide if further studies in children are needed.
Eligibility Criteria
Inclusion Criteria
- Children and adolescents up to 17 years old.
- Have advanced solid tumors (except for primary brain tumors) or specific types of non-Hodgkin's lymphoma, such as primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma.
- The cancer must have worsened or not responded to standard treatments, and no other standard treatments are available.
- Must provide a tumor sample if available.
- Must have measurable disease.
- No previous treatment with immune-based therapies.
- Must have good organ and bone marrow function.
- Must have a life expectancy of at least 3 months.
Exclusion Criteria
- History of organ transplant (some exceptions may apply for non-Hodgkin's lymphoma after discussion with the study sponsor).
- History of bone marrow transplant may be allowed after discussion with the study sponsor.
- Have or had autoimmune or inflammatory disorders (some exceptions may apply).
- Have uncontrolled illnesses.
- Have a history of immune system deficiencies.
- Have active infections, including tuberculosis, hepatitis B or C, or HIV.
- Have unresolved side effects from previous cancer treatments that are moderate to severe.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 21231 | Baltimore | Maryland |
| Research Site | 02115 | Boston | Massachusetts |
| Research Site | 11040 | New Hyde Park | New York |
| Research Site | 73104 | Oklahoma City | Oklahoma |
| Research Site | 29425 | Charleston | South Carolina |
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