48 Participants Needed

Eribulin + Irinotecan + Temozolomide for Cancer

FH
Overseen ByFiorela Hernandez Tejada, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking other anti-cancer medications and investigational drugs before participating. The protocol does not specify about other types of medications, so it's best to discuss your current medications with the trial team.

Is the combination of Eribulin, Irinotecan, and Temozolomide safe for humans?

The combination of Irinotecan and Temozolomide has been studied in humans, showing some dose-limiting side effects like diarrhea, low white blood cell count (neutropenia), and low platelet count (thrombocytopenia). Adjustments in dosing are being explored to improve safety, but some dosing regimens have been found intolerable due to gastrointestinal issues.12345

What makes the drug combination of Eribulin, Irinotecan, and Temozolomide unique for cancer treatment?

This drug combination is unique because it combines Eribulin, which disrupts cancer cell division, with Irinotecan and Temozolomide, which have shown enhanced effects when used together, potentially offering a more effective treatment for certain cancers compared to using each drug alone.13567

What evidence supports the effectiveness of the drug combination of Eribulin, Irinotecan, and Temozolomide for cancer?

Research shows that the combination of Irinotecan and Temozolomide has been effective in treating various cancers, including glioblastoma and neuroblastoma, with some studies indicating that the combination works better than each drug alone. This suggests potential effectiveness for the combination with Eribulin, although specific data for this exact combination is not provided.13568

Who Is on the Research Team?

FH

Fiorela Hernandez Tejada, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 1 to 25 with relapsed or refractory solid tumors. Participants need proper kidney, liver, and bone marrow function, no severe infections or allergies to cephalosporins, and can't be pregnant. They must have recovered from previous treatments and not received certain drugs recently.

Inclusion Criteria

I have had irinotecan or temozolomide alone, but not together.
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age, SGPT (ALT) ≤ 3 x ULN, Serum albumin ≥ 2gm/dL
I have recovered from graft versus host disease, don't need immunosuppressants, and it's been over 3 months since my transplant.
See 11 more

Exclusion Criteria

I do not have an ongoing severe infection or have been treated for C. difficile recently.
I am a child under the care of an organization or institution.
I haven't taken growth factors or other cancer treatments in the last 7 days.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Participants receive varying doses of eribulin to determine the maximum tolerated dose in combination with irinotecan and temozolomide

8 weeks

Dose Expansion

Participants receive the recommended dose combination based on their disease type in one of three treatment arms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease response and symptom relief

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eribulin
  • Irinotecan
  • Temozolomide
Trial Overview The study aims to determine the safe dose of eribulin when combined with irinotecan and temozolomide in treating stubborn solid tumors that haven't responded well to other therapies.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Arm D: Dose finding levels 0,-1 and -2Experimental Treatment3 Interventions
Group II: Arm C: Dose expansion- other solid tumor histologiesExperimental Treatment3 Interventions
Group III: Arm B: Dose expansion -RhabdomyosarcomaExperimental Treatment3 Interventions
Group IV: Arm A: Dose expansion-Ewings sarcomaExperimental Treatment3 Interventions

Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Halaven for:
🇺🇸
Approved in United States as Halaven for:
🇯🇵
Approved in Japan as Halaven for:
🇨🇦
Approved in Canada as Halaven for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

Irinotecan, a derivative of camptothecin, has shown significant activity against recurrent malignant glioma in clinical trials, confirming its potential as a treatment option for this aggressive brain tumor.
Combining irinotecan with alkylating agents like BCNU or temozolomide enhances its antitumor effects, leading to ongoing Phase II trials to evaluate these combinations in adults with malignant glioma.
The emerging role of irinotecan (CPT-11) in the treatment of malignant glioma in brain tumors.Friedman, HS., Keir, ST., Houghton, PJ.[2018]
This phase I study involving 49 patients aimed to identify the maximum tolerated doses and dose-limiting toxicities of irinotecan and temozolomide, revealing significant gastrointestinal toxicities such as diarrhea and neutropenia at certain dose levels.
Two partial responses were observed in patients with glioblastoma and head and neck cancer, indicating some efficacy of the drug combination, although the recommended doses for phase II trials are still being determined due to ongoing patient accrual.
Phase I. Trial of irinotecan and temozolomide in patients with solid tumors.Jones, SF., Gian, VG., Greco, FA., et al.[2018]
Temozolomide is a promising drug for combination therapies due to its ability to cross the blood-brain barrier, good safety profile, and effectiveness against solid tumors like malignant glioma, especially when combined with carmustine or irinotecan.
Studies indicate that administering carmustine before temozolomide results in lower toxicity and a higher maximum tolerated dose, while the combination of temozolomide followed by irinotecan shows greater effectiveness than either drug alone.
Temozolomide in combination with other cytotoxic agents.Prados, M.[2019]

Citations

The emerging role of irinotecan (CPT-11) in the treatment of malignant glioma in brain tumors. [2018]
Phase I. Trial of irinotecan and temozolomide in patients with solid tumors. [2018]
Temozolomide in combination with other cytotoxic agents. [2019]
Antitumor activity of temozolomide combined with irinotecan is partly independent of O6-methylguanine-DNA methyltransferase and mismatch repair phenotypes in xenograft models. [2022]
Phase I trial of oral irinotecan and temozolomide for children with relapsed high-risk neuroblastoma: a new approach to neuroblastoma therapy consortium study. [2021]
Irinotecan in lymphoma, leukemia, and breast, pancreatic, ovarian, and small-cell lung cancers. [2018]
Phase I study of temozolomide and irinotecan for recurrent malignant gliomas in patients receiving enzyme-inducing antiepileptic drugs: a north american brain tumor consortium study. [2021]
Temozolomide and intravenous irinotecan for treatment of advanced Ewing sarcoma. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security