RECRUITING

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

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Conditions

Refractory Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-16
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06006273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: Patients must be \> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.
  2. * Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.
  3. * Disease Status: Patients must have evaluable disease.
  4. * 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).
  5. * Performance Level: Karnofsky ≥ 50% for patients \>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I)
  6. * 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.
  7. * Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  8. 1. Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim.
  9. 2. 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.
  10. 3. 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.
  11. * Organ Function Requirements
  12. * Bone Marrow Function:
  13. 1. Peripheral absolute neutrophil count (ANC) ≥ 750/µL
  14. 2. Platelet count ≥ 75,000/µL (no platelet transfusion within 7 days prior to obtaining laboratory result)
  15. * Adequate Renal Function:
  16. * Adequate Liver Function:
  17. 1. Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age
  18. 2. SGPT (ALT) ≤ 3 x ULN
  19. 3. 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.
  1. * Significant organ dysfunction, not meeting inclusion criteria.
  2. * Pediatric subjects who are considered wards of some entity
  3. * Pregnancy or Breast-Feeding
  4. * 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.
  5. * Concomitant Medications:
  6. * Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.
  7. * Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to Prior Therapy, section 2.1.5)
  8. * Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to Prior Therapy, section 2.1.5.1)
  9. * Medication Allergy:
  10. 1. Allergy or intolerance to agents on this protocol: irinotecan, temozolomide, or eribuin
  11. 2. Allergy to cephalosporins, without a reasonably available antibiotic alternative
  12. * Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.

Contacts and Locations

Study Contact

Fiorela Hernandez Tejada, MD
CONTACT
(832) 306-9802
fnhernandez@mdanderson.org

Principal Investigator

Fiorela Hernandez Tejada, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Fiorela Hernandez Tejada, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-16
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-08-16
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Refractory Solid Tumors