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Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

ConditionMetastatic Ewing Sarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient. Such principles include an initial intense first strike to deplete the bulk of the cancer cells, followed by a series of sequential second strikes towards eliminating residual, resistant populations, followed by a prolonged period of maintenance chemotherapy to eliminate any remnant cells, using agents generally regarded to be active against newly diagnosed ES.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be >1 year of age. There is no upper age limit.

Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy.

Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.

Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may be from a primary or metastatic site.

Disqualifiers

Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.

Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.

Patients who are receiving any other investigational agents for their cancer.

Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Vincristine

    Drug

    IV Push

  • Doxorubicin

    Drug

    IV

  • Cyclophosphamide

    Drug

    IV and Maintenance PO

  • Ifosfamide

    Drug

    IV

  • Actinomycin

    Drug

    IV

  • Irinotecan

    Drug

    IV

  • Cabozantinib

    Drug

    PO

  • Topotecan

    Drug

    IV

  • Temozolomide

    Drug

    IV

  • Etoposide

    Drug

    PO

  • Liposomal doxorubicin

    Drug

    IV

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Sequential TherapyExperimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

Feasibility and Safety - Consolidation

The treatment will be considered feasible if 70% of Ewing sarcoma patients make it through consolidation.

Time frame
16 months
2

Feasibility and Safety - Maintenance

The treatment will be considered feasible if 50% of Ewing sarcoma patients make it through 6 cycles of maintenance.

Time frame
16 months

Secondary outcomes

1

Event-Free Survival

EFS is defined as time from treatment initiation to event which includes (1) recurrence, (2) secondary malignancy, and (3) death due to any cause.

Time frame
3 years
2

Off Treatment Event Free Survival

otEFS is defined as time from treatment initiation to event 66 which includes (1) any recurrence (local or regional, or distant) that leads to coming off protocol therapy and (2) death due to any cause.

Time frame
3 years
3

Overall Survival

The time to event endpoint of overall survival is defined as the duration of time from diagnosis to death or last follow-up timepoint, where event would be death from any cause.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Pediatric Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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