Irinotecan and Temozolomide for Ewing Sarcoma
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedStudy Start
First participant enrolled
February 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedNovember 1, 2022
October 1, 2022
4.8 years
November 26, 2017
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Object response rate(ORR) at 12 weeks
complete response (CR) + partial response (PR) at 12 weeks
4 months
Secondary Outcomes (3)
Progression-free survival(PFS)
2 years
Overall survival(OS)
2 years
Duration of response(DOR)
2 years
Study Arms (2)
5d VIT (irinotecan, temozolomide and vincristine)
EXPERIMENTALIrinotecan 50mg/m2/d IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
5d x 2 VIT (irinotecan, temozolomide and vincristine)
ACTIVE COMPARATORIrinotecan 20mg/m2/d IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions
vincristine 1.5mg/m2 iv D1,D8
Temozolomide 100mg/m2/d iv on days 1-5.
Eligibility Criteria
You may qualify if:
- Histologically confirmed Ewing sarcoma.
- Evidence of Ewing sarcoma translocation by fluorescence in situ hybridization (FISH) or real-time polymerase chain reaction (RT-PCT).
- Recurrent or refractory tumors with no known curative treatment options according to the judgment of the investigator.
- Prior treatment consisted of standard Ewing Sarcoma chemotherapy agents including doxorubicin, vincristine, cyclophosphamide, ifosfamide and etoposide; metastatic relapsed and unresectable progressive disease (PD);
- Life expectancy of ≥ 3 months.
- Eastern Cooperative Oncology Group performance status 0-1
- Measurable disease on CT or MRI by RECIST 1.1.
- Adequate organ function.
- Time elapsed from previous therapy must be ≥ 3 weeks for systemic therapy, ≥ 2 weeks for radiation therapy or major surgery.
- Patients who have undergone autologous hematopoietic stem cell transplantation are eligible once they have recovered from all toxicities from therapy.
- Patients who have received allogeneic hematopoietic stem cell transplantation will be eligible 6 months after the procedure provided there is no evidence of active graft-versus-host disease and immunosuppressive treatment has been discontinued for at least 30 days.
- Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of central nervous system metastatic disease, have been off glucocorticoids for at least 4 weeks, have no overt evidence of neurological deficit and are ≥ 6 weeks from completion of brain irradiation.
- Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication.
You may not qualify if:
- Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the investigational agent or be likely to interfere with the study procedures or results.
- Patients with baseline corrected QT interval(QTc) \> 480 msec.
- Known hypersensitivity to any of the components of niraparib or prior hypersensitivity reactions to that class of drugs.
- Known hypersensitivity reaction to temozolomide or any of its components, or dacarbazine (DTIC) or any of its components, and irinotecan or any of its components.
- Concomitant use of any other investigational or anticancer agent(s).
- Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
- Inability to swallow capsules.
- Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
- Known persistent (\> 4 weeks) ≥ Grade 2 neutropenia, ≥ Grade 2 thrombocytopenia or \> Grade 3 anemia from prior cancer therapy.
- Other kinds of malignant tumors at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Guo, Ph.D, M.D.
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Musculoskeletal Tumor Center
Study Record Dates
First Submitted
November 26, 2017
First Posted
December 2, 2017
Study Start
February 7, 2018
Primary Completion
November 28, 2022
Study Completion
February 28, 2025
Last Updated
November 1, 2022
Record last verified: 2022-10