Combination of Vincristine and Irinotecan with or without Temozolomide (VI or VIT) in children and adults with refractory or relapsed rhabdomyosarcoma
| ISRCTN | ISRCTN66172474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66172474 |
| EudraCT/CTIS number | 2010-023135-42 |
| ClinicalTrials.gov number | NCT01355445 |
| Secondary identifying numbers | 11903 |
- Submission date
- 22/06/2012
- Registration date
- 22/06/2012
- Last edited
- 29/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-temozolomide-for-rhabdomyosarcoma
Contact information
Miss Bridget Large
Scientific
Scientific
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 414 8040 |
|---|---|
| VIT0910@trials.bham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | International randomized phase II trial of the combination of Vincristine and Irinotecan with or without Temozolomide (VI or VIT) in children and adults with refractory or relapsed rhabdomyosarcoma |
| Study acronym | VIT-0910 |
| Study objectives | This is an international open-label, multicenter, randomized phase II trial Primary objective: To evaluate the efficacy of the combination of temozolomide with vincristine and irinotecan in children and adult patients with refractory or relapsed rhabdomyosarcoma as assessed by confirmed objective tumor response Secondary objective: To evaluate the safety, tolerability and efficacy of VIT and VI alone as assessed by: duration of response, time to tumor progression, time to treatment failure, overall survival and adverse event profile. |
| Ethics approval(s) | South Central Oxford A, South West REC Centre, 18/01/2012, ref: 11/SC/0410 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Sarcoma; Disease: Soft Tissue |
| Intervention | Arm A - VI: Day (D)1 and D8 Vincristine 1.5 mg/m2 (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg) D1 to D5 Irinotecan 50 mg/m2/d, IV 1 cycle/ 21 days maximum of 12 cycles Arm B - VIT: D1 to D5 Temozolomide 125 mg/m2/d, PO* D1 and D8 Vincristine 1.5 mg/m2 (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg) D1 to D5 Irinotecan 50 mg/m2/d, IV 1 cycle/ 21 days maximum of 12 cycles *The dose will be escalated to 150 mg/m2/day at cycle 2 for patients who do not experience > grade 3 toxicity of any kind Follow Up Length: 60 month(s) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Vincristine, irinotecan and temozolomide |
| Primary outcome measure | Complete or partial tumour response is assessed after the first 2 cycles of treatment which must be confirmed by a follow-up objective tumour assessment. |
| Secondary outcome measures | 1. Duration of response 2. Time to tumour progression 3. Time to treatment failure 4. Overall survival and adverse event profile |
| Overall study start date | 03/02/2011 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 20 |
| Key inclusion criteria | Tumor characteristics: 1. Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma (new biopsy recommended) 2. Relapsed or refractory disease which has failed standard treatment approaches 3. Patients must have measurable disease defined as lesions that can be measured in three dimensions by medical imaging techniques such as computerised tomography (CT) or magnetic resonance imaging (MRI). Ascites, pleural fluid, bone marrow disease and lesions seen on Tc scintigraphy or positron emission tomography (PET) scan only are not considered measurable. Patient characteristics: 1. Age > 6 months and < 50 years 2. Karnofsky performance status (PS) 70-100% (for patients > 12 years of age) OR Lansky Play Score 70-100% (for patients = 12 years of age) 3. Life expectancy >= 12 weeks 4. Adequate bone marrow function : 4.1. Absolute neutrophil count >= 1000/mm3 4.2. Platelet count >= 100,000/mm3 (transfusion independent) 4.3. Hemoglobin >= 8.5 g/dL (transfusion allowed) 5. Adequate renal function 5.1. Serum creatinine < 1.5 X ULN for age 5.2. If serum creatinine > 1.5 ULN, creatinine clearance or radioisotope GFR) must be > 70 ml/min/1.73 m² 6. Adequate hepatic function : 6.1. Total bilirubin = 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilberts syndrome 6.2. ALT and AST < 2.5 X ULN for age 7. Negative pregnancy test in females with childbearing potential 8. Fertile patients must use effective contraception 9. No active > grade 2 diarrhea or uncontrolled infection 10. No other malignancy, including secondary malignancy 11. Patient affiliated with a health insurance system. Applicable for French patients only 12. Written informed consent of patient and/or parents/ guardians Prior or concurrent therapy: 1. More than 3 weeks since prior radiation therapy to the site of any progressive lesion that will be identified as a target lesion to measure tumor response 2. At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea, 2 weeks for vincristine, vinorelbine, vinblastine and lowdose cyclophosphamide) 3. No concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, or carbamazepine 4. No concurrent administration of any of the following : rifampicin, voriconazole, itraconazole, ketoconazole, aprepitant 5. No prior irinotecan or temozolomide administration 6. Prior administration of vincristine is allowed 7. Concurrent palliative radiation therapy to sites allowed except for the main measurable target lesion 8. Prior allo- or autologous SCT allowed; Upper Age Limit 50 years ; Lower Age Limit 6 months |
| Key exclusion criteria | 1. Inclusion criteria failure 2. Concomitant anticancer treatment 3. Know hypersensitivity to any component of study drugs or ingredients 4. Pregnancy or breast feeding 5. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 6. Neuromuscular disorders (e.g. Charcot-Marie Tooth disease) 7. Uncontrolled intercurrent illness or active infection 8. Unavailable for medical follow-up (geographic, social or mental reasons) |
| Date of first enrolment | 09/02/2012 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- France
- Italy
- Netherlands
- Spain
- United Kingdom
Study participating centre
School of Cancer Sciences
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Centre Oscar Lambret (France)
Government
Government
c/o : Anne-Sophie DEFACHELLES, MD
3 rue Frédéric Combemale
Lille
59020
France
| Phone | +33 03 25 008 088 |
|---|---|
| as-defachelles@o-lambret.fr | |
"ROR" |
https://ror.org/03xfq7a50 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the trial will be published in a peer reviewed scientific journal. At the end of the study, a report will be written by the sponsor, and then validated by the coordinating investigator (Dr. AS Defachelles) of trial VIT-0910. No publication or presentation of the results of this trial will be done without the permission of the sponsor. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | Cancer Research UK lay summary of results | 23/11/2021 | 29/11/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/11/2021: A plain English results link has been added to the trial outputs table.
15/03/2017: The following changes have been made to the record:
1. The overall trial dates have been updated from 30/06/2012 - 30/04/2014 to 03/02/2011 - 31/12/2021 and the recruitment dates have been updated from 30/06/2012 - 30/04/2014 to 09/02/2012 - 31/12/2017.
N.B. The trial was opened to recruitment between 09/02/2012 and 19/06/2014 , which is when the protocol accrued to target (80 patients). The protocol was then amended to increase the recruitment target to 120 patients and the trial was reopened 12/04/2016.
2. The publication and dissemination plan and IPD Sharing plan have been added
06/12/2016: No publications found in PubMed, verifying study status with principal investigator.
