Ewing SarcomaPhase 2NCT03359005
Irinotecan and Temozolomide for Ewing Sarcoma
A Phase 2 study testing Vincristine and Temozolomide in people with Ewing Sarcoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ewing Sarcoma
- What is being tested?
- Vincristine and Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2018to 28 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100034
Jie Xu, 86 15901040835, xujie_pkuph@sina.com
Wei Guo, M.D., Ph.D.
About this study
Official title: Irinotecan and Temozolomide for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy
The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma.
Read the detailed 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.
- Conditions
- Ewing Sarcoma
- Being tested
- Vincristine, Temozolomide
- Keywords
- Ewing Sarcoma, Irinotecan, Temozolomide
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
Also called VCR
vincristine 1.5mg/m2 iv D1,D8
TemozolomideDrug
Also called Temodar
Temozolomide 100mg/m2/d iv on days 1-5.
| Study group | Role | What they receive |
|---|---|---|
| 5d VIT (irinotecan, temozolomide and vincristine) | Experimental | Irinotecan 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. Receives: Drug: Vincristine; Drug: Temozolomide |
| 5d x 2 VIT (irinotecan, temozolomide and vincristine) | Active comparator | Irinotecan 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. Receives: Drug: Vincristine; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Object response rate(ORR) at 12 weeks
complete response (CR) + partial response (PR) at 12 weeks
Measured: 4 months
Secondary outcomes (3)
Progression-free survival(PFS)
Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Measured: 2 years
Overall survival(OS)
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
Measured: 2 years
Duration of response(DOR)
Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start7 Feb 2018
- Primary completion28 Nov 2022 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUO WEI, Peking University People's Hospital
- Investigators
- Wei Guo, Ph.D, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359005
- Sponsor's protocol ID
- PKUPH-EWS-01
- Status last verified
- Oct 2022
- First submitted
- 26 Nov 2017
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan and Temozolomide for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy
- ClinicalTrials.gov ID
- NCT03359005
- Acronym / sponsor ID
- PKUPH-EWS-01
- Conditions
- Ewing Sarcoma
- Keywords
- Ewing Sarcoma, Irinotecan, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5d VIT (irinotecan, temozolomide and vincristine) | Experimental | Drug: Vincristine, Drug: TemozolomideIrinotecan 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 comparator | Drug: Vincristine, Drug: TemozolomideIrinotecan 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VincristineAlso: VCRvincristine 1.5mg/m2 iv D1,D8 | Drug | 5d VIT (irinotecan, temozolomide and vincristine), 5d x 2 VIT (irinotecan, temozolomide and vincristine) |
| TemozolomideAlso: TemodarTemozolomide 100mg/m2/d iv on days 1-5. | Drug | 5d VIT (irinotecan, temozolomide and vincristine), 5d x 2 VIT (irinotecan, temozolomide and vincristine) |
Primary outcome
Object response rate(ORR) at 12 weeks
Time frame: 4 months
complete response (CR) + partial response (PR) at 12 weeks
3 secondary outcomes
Progression-free survival(PFS)
Time frame: 2 years
Overall survival(OS)
Time frame: 2 years
Duration of response(DOR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Ewing Sarcoma
Active, not recruitingPhase 3
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CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
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XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Guo, Ph.D, M.D. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vincristine and Temozolomide in people with Ewing Sarcoma, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Xu, M.D. (86-15901040835, xujie_pkuph@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Object response rate(ORR) at 12 weeks (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.