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New treatment option for Refractory Solid Tumors
Official title A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
ClinicalTrials.gov ID: NCT06006273
What this study is testing
What is Eribulin?
Eribulin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Age: Patients must be \> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.
- Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.
- Disease Status: Patients must have evaluable disease.
- Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids...
- Performance Level: Karnofsky ≥ 50% for patients \>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I)
You likely can't join if
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric people who are considered wards of some entity
- Pregnancy or Breast-Feeding
- Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human...
- Concomitant Medications:
- Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.
See the full eligibility criteria
- Age: Patients must be \> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.
- Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.
- Disease Status: Patients must have evaluable disease.
- Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids for 7 days).
- Performance Level: Karnofsky ≥ 50% for patients \>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I)
- Prior Therapy: Patients may have received prior therapy including single-agent irinotecan or temozolomide. Patients may not have previously been treated with combination therapy of irinotecan and temozolomide.
- Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim.
- XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation.
- Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no...
- Organ Function Requirements
- Bone Marrow Function:
- Peripheral absolute neutrophil count (ANC) ≥ 750/µL
- Platelet count ≥ 75,000/µL (no platelet transfusion within 7 days prior to obtaining laboratory result)
- Adequate Renal Function: a. Creatinine clearance or glomerular filtration rate ≥ 70ml/min/1.73m2 (calculated or measured as appropriate for age and level of concern by treating MD)
- Adequate Liver Function:
- Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age
- SGPT (ALT) ≤ 3 x ULN
- Serum albumin ≥ 2gm/dL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \>2.0 mg/dl or SGPT(ALT)\> 3 x ULN. Informed Consent: All patients...
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric people who are considered wards of some entity
- Pregnancy or Breast-Feeding
- Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Concomitant Medications:
- Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.
- Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to Prior Therapy, section 2.1.5)
- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to Prior Therapy, section 2.1.5.1)
- Medication Allergy:
- Allergy or intolerance to agents on this protocol: irinotecan, temozolomide, or eribuin
- Allergy to cephalosporins, without a reasonably available antibiotic alternative
- Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.