Irinotecan and Temozolomide for Ewing Sarcoma

STATUS

Recruiting
End date

Feb 28, 2025
participants needed

102
sponsor

Peking University People's Hospital

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Updated on 28 February 2022

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cyclophosphamide

immunosuppressive

vincristine

measurable disease

cell transplantation

irinotecan

temozolomide

ifosfamide

metastatic ewing's sarcoma

treatment consisted of

Summary

The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma.

Description

After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades. The anti-tumor activity of VIT was demonstrated by several studies in the past. However, the detailed schedule of VIT was not decided. Thus, the investigators explored the activity of 5-d shorter schedule of VIT and 5-d x2w longer schedule of VIT in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide.

Details

Condition	Ewing Sarcoma
Treatment	Temozolomide, Irinotecan, vincristine
Clinical Study Identifier	NCT03359005
Sponsor	Peking University People's Hospital
Last Modified on	28 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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

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Irinotecan and Temozolomide for Ewing Sarcoma