A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

NCT06006273 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2023-0163NCI-2023-06570
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (4)

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.

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.

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.

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.

Drug: Eribulin; Drug: Irinotecan; Drug: Temozolomide

Interventions

Eribulin DRUG

Given by vein (IV)

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

Irinotecan DRUG

Given by vein (IV)

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

Temozolomide DRUG

Given by PO

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

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 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 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

eribulin; Irinotecan; Temozolomide

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Fiorela Hernandez Tejada, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiorela Hernandez Tejada, MD

CONTACT

(832) 306-9802; fnhernandez@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: August 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-10

Locations

US (1)