Plain English Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-temozolomide-for-rhabdomyosarcoma
Trial website
Contact information
Type
Scientific
Primary contact
Miss Bridget Large
ORCID ID
Contact details
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 414 8040
VIT0910@trials.bham.ac.uk
Additional identifiers
EudraCT number
2010-023135-42
ClinicalTrials.gov number
NCT01355445
Protocol/serial number
11903
Study information
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
Acronym
VIT-0910
Study hypothesis
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
South Central Oxford A, South West REC Centre, 18/01/2012, ref: 11/SC/0410
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
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 trial start date
03/02/2011
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 80; UK Sample Size: 20
Participant 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)
Recruitment start date
09/02/2012
Recruitment end date
31/12/2017
Locations
Countries of recruitment
France, Italy, Netherlands, Spain, United Kingdom
Trial participating centre
School of Cancer Sciences
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Centre Oscar Lambret (France)
Sponsor details
c/o : Anne-Sophie DEFACHELLES
MD
3 rue Frédéric Combemale
Lille
59020
France
+33 03 25 008 088
as-defachelles@o-lambret.fr
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
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.
Intention to publish date
31/12/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list