Solid Tumor CancerPhase 1NCT06710821
Irinotecan Liposomes Combined with Temozolomide and Vincristine in the Treatment of Pediatric Patients with Solid Tumors
A Phase 1 study testing Liposomal irinotecan in combination with vincristine and temozolomide in people with Solid Tumor Cancer, run by Yizhuo Zhang.
Trial summary
A prospective, single-center Ia/Ib clinical study divided into two parts, including Phase Ia Dose Exploration and Phase Phase Ib Extension Phase. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- Liposomal irinotecan in combination with vincristine and temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1、 12 years old ≤ 18 years old, no gender restriction.
- 2. Karnofsky (≥ 16 years old) or Lansky (< 16 years old) physical condition score of at least 50.
- 3. Expected survival time of at least 12 weeks.
- 4.Cardiac function: A) LVEF ≥50% by cardiac ultrasound; B) no myocardial ischemia by electrocardiogram; C) no history of arrhythmia requiring pharmacological intervention before enrollment.
- 5、 Patients who met the clinical diagnostic criteria and were diagnosed with solid malignant tumors in children; and 6, Patients who have progressed, relapsed, or are refractory to first-line therapy (failed to achieve complete or partial remission after recent treatment); and
- 7, Measurable lesions (according to RECIST 1.1 criteria, CT/MRI scan length of tumor lesions ≥ 10mm, CT/MRI scan short diameter of lymph node lesions ≥ 15mm, measurable lesions have not received local treatment such as radiotherapy, cryotherapy, etc.); patients with neuroblastoma, at least one of which is diagnosed by Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and/or by Bone Marrow ( BM) morphology and/or a measurable lesion by mesoiodobenzylguanidine (MIBG) scan obtained within 4 weeks of enrollment (MRI or CT scan or X-ray measurable tumor);
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- 8. Patients must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy: A) Myelosuppressive chemotherapy: at least 21 days (42 days if nitrosourea was used previously) after the last myelosuppressive chemotherapy, including cytotoxic drugs given in a low-dose rhythmic regimen; B) Experimental drugs or anticancer treatments other than chemotherapy: not available for 28 days prior to the planned start of AI or VIT Use. Complete recovery from clinically significant toxicity of the treatment must be established; C) Hematopoietic Growth Factors: at least 14 days after the last administration of long-acting growth factors or 3 days after the last administration of short-acting growth factors; D) Immunotherapies: at least 42 days after completion of any type of immunotherapy (other than steroids), such as immune checkpoint inhibitors and tumor vaccines; E) X-Ray Therapy (XRT): local palliative E) X-Ray Therapy (XRT): at least 14 days after localized palliative XRT (small-bore); for other substantial bone marrow (BM) irradiation, must be completed at least 42 days; F) Stem Cell Infusion without Total Body Irradiation (TBI): no evidence of active graft-versus-host disease, and the transplantation or stem cell infusion must be completed at least 56 days after the infusion.
- 9. Laboratory tests at screening should fulfill the following conditions: A) Absolute neutrophil (ANC) ≥1.5×109/L (ANC ≥1.0×109/L if bone marrow infiltration); B) Platelet count (PLT) ≥75×109/L (bone marrow infiltration PLT ≥50×109/L); C) Bilirubin (combined + uncombined total) ≤1.5 upper limit of normal ( ULN), and patients with confirmed diagnosis of Gilbert's syndrome may be included in this group at the investigator's discretion; D) estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or serum creatinine (Cr) ≤1.5 ULN (calculated according to the standard Cockcroft-Gault formula); E) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (5 times the ULN if liver metastases are present)
- 10. be able to comply with outpatient treatment, laboratory monitoring, and required clinical visits during the study period; and
- 11. Parents/guardians of child or adolescent subjects are able to understand, agree to, and sign the study Informed Consent Form (ICF) and applicable Child Consent Form prior to initiation of any program-related procedures; subjects are able to give consent with parental/guardian consent (if applicable).
Who cannot join
- 1, Patients who have received prior irinotecan in combination with temozolomide and vincristine, or who have progressed after receiving irinotecan or temozolomide; and
- 2, P450 enzyme-inducing anticonvulsants (anticonvulsants affect irinotecan clearance); and
- 3. Active cardiovascular disease of previous or concurrent clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary artery disease, cardiac valve disease, cardiomyopathy, cardiac arrhythmias (including persistent atrial fibrillation, complete left bundle-branch block, and frequent premature ventricular episodes); or prolongation of the QT interval (QTc)> after the current corrected heart rate of 480 milliseconds; and cardiac function classified according to the New York Heart Association (NYHA). NYHA cardiac function classification (age > 3 years) or infant cardiac function criteria (age ≤ 3 years) or class III-IV cardiac insufficiency with a left ventricular ejection fraction (LVEF) < 50%, as indicated by color Doppler echocardiography; and
- 4. Prior severe chronic skin disease; and
- 5, Previous allergic asthma or severe allergic disease; 6, Uncontrolled hypertension and diabetes mellitus; and
- 6. Poorly controlled hypertension and diabetes mellitus.
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- 7. History of other tumors, except cervical cancer or basal cell carcinoma of the skin that has been cured; 8.
- 8. Hepatitis B surface antigen positive patients; and
- 9. Patients with HIV or syphilis infection; and
- 10. Patients who have previously received an organ transplant; and
- 11. Uncontrolled and active systemic bacterial, viral or fungal infections.
- 12. Contraindications to the use of high-dose hormones, such as uncontrolled hyperglycemia, gastric ulcers, or psychiatric disorders; and
- 13. History of severe neurologic or psychiatric disorders, including epilepsy or autism;
- 14. Patients who, in the judgment of the investigator, are not suitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I Clinical Study of Irinotecan Liposomes in Combination with Temozolomide and Vincristine in the Treatment of Patients with Relapsed/refractory Pediatric Solid Tumors
A prospective, single-center Ia/Ib clinical study divided into two parts, including Phase Ia Dose Exploration and Phase Phase Ib Extension Phase.
Read the detailed description
Phase Ia dose exploration phase:
Using a "3+3" study design, 15-30 eligible subjects will receive irinotecan liposome. Five dose groups of irinotecan liposome 40 mg/m2, 50 mg/m2, 65 mg/m2, 80 mg/m2, and 100 mg/m2 will be pre-determined for a 21-day cycle. The dose of liposomal irinotecan will be gradually increased from the low dose group to the high dose group, and DLT will be observed during the dosing cycle.The same subject will receive only one dose of liposomal irinotecan during the study period. All subjects will complete relevant protocol-specified investigations during the course of treatment to observe safety and initial efficacy.
Phase Ib Expansion Phase:
Based on the results of the Phase Ia dose-climbing phase, the Phase Ib study will be conducted at the RP dose of irinotecan liposomes, and all subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, preliminary efficacy, and so on.
- Conditions
- Solid Tumor Cancer
- Being tested
- Liposomal irinotecan in combination with vincristine and temozolomide
- Keywords
- Adolescent, solid tumors, VIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal irinotecan in combination with vincristine and temozolomideDrug
Vincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. Q3W, 4 cycles expected until disease progression or intolerable toxicity occurs
| Study group | Role | What they receive |
|---|---|---|
| VIT | Experimental | Vincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. Receives: Drug: Liposomal irinotecan in combination with vincristine and temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD)
maximum tolerated dose (MTD) of liposomal irinotecan in combination with temozolomide and vincristine in pediatric patients with relapsed/refractory pediatric solid tumors
Measured: 6 months
Secondary outcomes (2)
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Measured: 1 year
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Irinotecan liposome combined with temozolomide and vincristine
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yizhuo Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710821
- Sponsor's protocol ID
- CSPC-DEY- SARC-GD01
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Irinotecan Liposomes in Combination with Temozolomide and Vincristine in the Treatment of Patients with Relapsed/refractory Pediatric Solid Tumors
- ClinicalTrials.gov ID
- NCT06710821
- Acronym / sponsor ID
- CSPC-DEY- SARC-GD01
- Conditions
- Solid Tumor Cancer
- Keywords
- Adolescent, solid tumors, VIT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yizhuo ZhangUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2024 (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.
A prospective, single-center Ia/Ib clinical study divided into two parts, including Phase Ia Dose Exploration and Phase Phase Ib Extension Phase.
Detailed description
Phase Ia dose exploration phase:
Using a "3+3" study design, 15-30 eligible subjects will receive irinotecan liposome. Five dose groups of irinotecan liposome 40 mg/m2, 50 mg/m2, 65 mg/m2, 80 mg/m2, and 100 mg/m2 will be pre-determined for a 21-day cycle. The dose of liposomal irinotecan will be gradually increased from the low dose group to the high dose group, and DLT will be observed during the dosing cycle.The same subject will receive only one dose of liposomal irinotecan during the study period. All subjects will complete relevant protocol-specified investigations during the course of treatment to observe safety and initial efficacy.
Phase Ib Expansion Phase:
Based on the results of the Phase Ia dose-climbing phase, the Phase Ib study will be conducted at the RP dose of irinotecan liposomes, and all subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, preliminary efficacy, and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Irinotecan liposome combined with temozolomide and vincristine
| Arm | Type | Receives |
|---|---|---|
| VIT | Experimental | Drug: Liposomal irinotecan in combination with vincristine and temozolomideVincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 1、 12 years old ≤ 18 years old, no gender restriction.
- 2. Karnofsky (≥ 16 years old) or Lansky (< 16 years old) physical condition score of at least 50.
- 3. Expected survival time of at least 12 weeks.
- 4.Cardiac function: A) LVEF ≥50% by cardiac ultrasound; B) no myocardial ischemia by electrocardiogram; C) no history of arrhythmia requiring pharmacological intervention before enrollment.
- 5、 Patients who met the clinical diagnostic criteria and were diagnosed with solid malignant tumors in children; and 6, Patients who have progressed, relapsed, or are refractory to first-line therapy (failed to achieve complete or partial remission after recent treatment); and
Key exclusion criteria (14 listed)
- 1, Patients who have received prior irinotecan in combination with temozolomide and vincristine, or who have progressed after receiving irinotecan or temozolomide; and
- 2, P450 enzyme-inducing anticonvulsants (anticonvulsants affect irinotecan clearance); and
- 3. Active cardiovascular disease of previous or concurrent clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary artery disease, cardiac valve disease, cardiomyopathy, cardiac arrhythmias (including persistent atrial fibrillation, complete left bundle-branch block, and frequent premature ventricular episodes); or prolongation of the QT interval (QTc)> after the current corrected heart rate of 480 milliseconds; and cardiac function classified according to the New York Heart Association (NYHA). NYHA cardiac function classification (age > 3 years) or infant cardiac function criteria (age ≤ 3 years) or class III-IV cardiac insufficiency with a left ventricular ejection fraction (LVEF) < 50%, as indicated by color Doppler echocardiography; and
- 4. Prior severe chronic skin disease; and
- 5, Previous allergic asthma or severe allergic disease; 6, Uncontrolled hypertension and diabetes mellitus; and
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 |
|---|---|---|
| Liposomal irinotecan in combination with vincristine and temozolomideVincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. Q3W, 4 cycles expected until disease progression or intolerable toxicity occurs | Drug | VIT |
Primary outcome
maximum tolerated dose (MTD)
Time frame: 6 months
maximum tolerated dose (MTD) of liposomal irinotecan in combination with temozolomide and vincristine in pediatric patients with relapsed/refractory pediatric solid tumors
2 secondary outcomes
Incidence of adverse events
Time frame: 1 year
Objective Response Rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal irinotecan in combination with vincristine and temozolomide in people with Solid Tumor Cancer, run by Yizhuo Zhang.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang Professor (18819241079, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose (MTD) (time frame: 6 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 29 Nov 2024.