Refractory Solid TumorsPhase 1NCT06006273
A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
A Phase 1 study testing Eribulin, Irinotecan and Temozolomide in people with Refractory Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Refractory Solid Tumors
- What is being tested?
- Eribulin, Irinotecan and Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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 longer requiring transfusion of platelets or injection of colony stimulating factors.
- 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:
- 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 ≥ 18 years of age must sign a written informed consent. For patients < 18 years old, the patient's parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor. Childhood Assent, when age appropriate as per institutional guidelines, should be signed by the participating patient. Consent may be obtained virtually, as per institutional guidelines.
Who cannot join
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric subjects 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Fiorela Hernandez Tejada, MD, 832-306-9802, fnhernandez@mdanderson.org
Fiorela Hernandez Tejada, MD
About this study
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.
Read the detailed description
Primary Objectives:
- To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of eribulin in combination with fixed doses of irinotecan and temozolomide.
- To determine the safety and tolerance of Eribulin when given in conjunction with Irinotecan and Temozolamide (IT) in children with refractory and relapsed (R/R) solid tumors.
Secondary Objectives:
--To observe and record disease response (anti-tumor activity). Although the clinical benefit of Eribulin when given together with Irinotecan and Temozolamide has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best Overall Response (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS).
- Conditions
- Refractory Solid Tumors
- Being tested
- Eribulin, Irinotecan, Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Given by vein (IV)
IrinotecanDrug
Given by vein (IV)
TemozolomideDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Dose expansion-Ewings sarcoma | Experimental | The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. Receives: Drug: Eribulin; Drug: Irinotecan; Drug: Temozolomide |
| Arm B: Dose expansion -Rhabdomyosarcoma | Experimental | The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. Receives: Drug: Eribulin; Drug: Irinotecan; Drug: Temozolomide |
| Arm C: Dose expansion- other solid tumor histologies | Experimental | The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. Receives: Drug: Eribulin; Drug: Irinotecan; Drug: Temozolomide |
| Arm D: Dose finding levels 0,-1 and -2 | Experimental | The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. Receives: Drug: Eribulin; Drug: Irinotecan; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start16 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiorela Hernandez Tejada, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006273
- Sponsor's protocol ID
- 2023-0163
- Other IDs
- NCI-2023-06570
- Status last verified
- May 2026
- First submitted
- 17 Aug 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2023-0163
- Conditions
- Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
- To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of eribulin in combination with fixed doses of irinotecan and temozolomide.
- To determine the safety and tolerance of Eribulin when given in conjunction with Irinotecan and Temozolamide (IT) in children with refractory and relapsed (R/R) solid tumors.
Secondary Objectives:
--To observe and record disease response (anti-tumor activity). Although the clinical benefit of Eribulin when given together with Irinotecan and Temozolamide has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best Overall Response (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Dose expansion-Ewings sarcoma | Experimental | Drug: Eribulin, Drug: Irinotecan, Drug: TemozolomideThe first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. |
| Arm B: Dose expansion -Rhabdomyosarcoma | Experimental | Drug: Eribulin, Drug: Irinotecan, Drug: TemozolomideThe first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. |
| Arm C: Dose expansion- other solid tumor histologies | Experimental | Drug: Eribulin, Drug: Irinotecan, Drug: TemozolomideThe first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. |
| Arm D: Dose finding levels 0,-1 and -2 | Experimental | Drug: Eribulin, Drug: Irinotecan, Drug: TemozolomideThe first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase. |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (12 listed)
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric subjects 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EribulinGiven by vein (IV) | Drug | Arm A: Dose expansion-Ewings sarcoma, Arm B: Dose expansion -Rhabdomyosarcoma, Arm C: Dose expansion- other solid tumor histologies, Arm D: Dose finding levels 0,-1 and -2 |
| IrinotecanGiven by vein (IV) | Drug | Arm A: Dose expansion-Ewings sarcoma, Arm B: Dose expansion -Rhabdomyosarcoma, Arm C: Dose expansion- other solid tumor histologies, Arm D: Dose finding levels 0,-1 and -2 |
| TemozolomideGiven by PO | Drug | Arm A: Dose expansion-Ewings sarcoma, Arm B: Dose expansion -Rhabdomyosarcoma, Arm C: Dose expansion- other solid tumor histologies, Arm D: Dose finding levels 0,-1 and -2 |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiorela Hernandez Tejada, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eribulin, Irinotecan and Temozolomide in people with Refractory Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiorela Hernandez Tejada, MD ((832) 306-9802, fnhernandez@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.