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RHABDOMYOSARCOMAPhase 2VIT-0910NCT01355445

Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma

A Phase 2 study testing Vincristine, Irinotecan and Vincristine, Irinotecan, Temozolomide in people with RHABDOMYOSARCOMA, run by Centre Oscar Lambret at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma. Read more about this study

Who is it for?
Ages 6 months to 50 years
Conditions the study is for
RHABDOMYOSARCOMA
What is being tested?
Vincristine, Irinotecan and Vincristine, Irinotecan, Temozolomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
16 sitesFrance
Study dates
Jan 2012to May 2019
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 6 months to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • TUMOR CHARACTERISTICS :
  • Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma (RMS) (new biopsy recommended)
  • Relapsed or refractory disease which has failed standard treatment approaches
  • Patients must have measurable disease defined as lesions that can be measured in 3 dimensions by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease and lesions seen on Tc scintigraphy or PET scan only are not considered measurable for these patients
  • PATIENT CHARACTERISTICS :
  • Age > 6 months and ≤ 50 years
Show all 39Show fewer
  • Karnofsky performance status (PS) 70-100% (for patients > 12 years of age) OR Lansky Play Score 70-100% (for patients ≤ 12 years of age)
  • Life expectancy ≥ 12 weeks
  • Adequate bone marrow function :
  • Absolute neutrophil count ≥ 1000/mm3; and ≥ 500/mm3 in case of bone marrow disease
  • Platelet count ≥ 100000/mm3 ; and ≥ 75000/mm3 in case of bone marrow disease (transfusion independent)
  • Hemoglobin ≥ 8.5 g/dl (transfusion allowed)
  • Adequate renal function
  • Serum creatinine ≤ 1.5 X ULN for age
  • If serum creatinine > 1.5 ULN, creatinine clearance (or radioisotope GFR) must be >70 ml/min/1.73 m²
  • Adequate hepatic function :
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilbert's syndrome
  • ALT and AST ≤ 2.5 times ULN for age
  • Negative pregnancy test in females with childbearing potential
  • Fertile patients must use effective contraception
  • No active > grade 2 diarrhea or uncontrolled infection
  • No other malignancy, including secondary malignancy
  • Patient affiliated with a health insurance system. Applicable for French patients only Written informed consent of patient and/or parents/guardians
  • PRIOR or CONCURRENT THERAPY :
  • 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
  • At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea. 2 weeks for vincristine, vinblastine, vinorelbine or low dose cyclophosphamide)
  • No concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital or carbamazepine
  • No concurrent administration of any of the following: rifampicin, voriconazole,itraconazole, ketoconazole, aprepitant, St John's Wort
  • No prior irinotecan or temozolomide administration
  • Prior vincristine administration allowed
  • Concurrent palliative radiation therapy to sites allowed other than the main measurable target
  • Prior allo- or autologous SCT allowed
  • Concomitant anti-cancer treatment
  • Know hypersensitivity to any component of study drugs or ingredients
  • Pregnancy or breast feeding
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Neuromuscular disorders (e.g. Charcot-Marie Tooth disease)
  • Uncontrolled intercurrent illness or active infection
  • Unavailable for medical follow-up (geographic, social or psychological reasons)

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU d'Amiens Picardie Site Sud

    Amiens

  • Hôpital des Enfants, Groupe Hospitalier Pellegrin

    Bordeaux

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • CHU, Hôpital d'Enfants de la Timone

    Marseille

  • Hôpital Arnaud de Villeneuve - CHU

    Montpellier

  • CHU, Hôpital Mère enfants

    Nantes

  • Hôpital Armand Trousseau

    Paris

  • Institut Curie

    Paris

  • Hôpital Jean Bernard

    Poitiers

  • CHU Rennes - Hôpital Sud

    Rennes

  • CHU St Etienne - Hôpital Nord

    Saint-Etienne

  • Hôpital des enfants

    Toulouse

  • CHRU

    Tours

  • CHRU Hôpital d'Enfants

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official 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

This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma.

Read the detailed description

The dose of vincristine will be 1.5 mg/m² or 0.05 mg/kg for patient ≤ 10 kg (maximum 2 mg) and will be administered by direct intravenous infusion on day 1 and 8 of each course, before irinotecan.

The dose of irinotecan will be 50 mg/m²/d. Irinotecan will be given intravenously over 1 hour on days 1-5 of each course, one hour following the administration of temozolomide.

In the absence of any contraindication (ie known allergies), treatment with oral cefixime 8 mg/kg once daily (maximum daily dose 400 mg) is recommended and will be started 2 days before chemotherapy until day 7.

Temozolomide will be given according to the randomization. The starting dose of temozolomide will be 125 mg/m²/d. The dose of temozolomide will be escalated to 150 mg/m²/day at cycle 2 for patients who do not experience > grade 3 toxicity of any kind. Temozolomide will be given orally, on an empty stomach, on days 1 through 5 of each course.

Dose reductions and/or administration delays will be performed using specific predefined rules to accommodate individual patient tolerance of treatment and to maintain optimal dose intensity.

Being tested
Vincristine, Irinotecan, Vincristine, Irinotecan, Temozolomide
Medical subject headings
Rhabdomyosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vincristine, IrinotecanDrug

    Also called Vincristine-Irinotecan

    • D1 and D8: Vincristine 1.5 mg/m² (max 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

  • Vincristine, Irinotecan, TemozolomideDrug

    Also called Vincristine-Irinotecan-Temozolomide

    • D1 to D5: Temozolomide 125 mg/m²/d, PO (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)
    • 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
Study groups in NCT01355445
Study groupRoleWhat they receive
Vincristine / IrinotecanActive comparatorVincristine, Irinotecan Vincristine :1.5 mg/m² (max 2mg), IV Irinotecan : Irinotecan 50 mg/m²/d, IV
Receives: Drug: Vincristine, Irinotecan
Vincristine / Irinotecan / TemozolomideExperimentalVincristine, Irinotecan, Temozolomide
Receives: Drug: Vincristine, Irinotecan, Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumour response and progression in each treatment arm.

    The primary efficacy endpoint is defined as the proportion of patients who had a documented complete or partial tumour response occurring after the first 2 cycles of treatment which must be confirmed by a follow-up objective tumour assessment obtained within 4-5 weeks after the initial documentation.

    Measured: at least 6 weeks (two cycles of treatment)

Secondary outcomes (5)

  1. To assess the duration of tumor response in each treatment arm

    The duration of tumour response is defined as the time from first documentation of objective tumour response to the first objective or clinical documentation of progression

    Measured: During all the study

  2. To determine the time to tumor progression in each treatment arm

    The time to tumor progression: the time from the date of first treatment administration to the date of first objective or clinical documentation of tumour progression or death due to any cause

    Measured: During all the study

  3. To assess the time to treatment failure in each treatment arm

    The time to treatment failure is defined as the time from the date of first treatment administration to the first documentation of tumour progression, discontinuation of study treatment before one year, or death, whichever occurs first

    Measured: Before 1 year

  4. To assess the overall survival in each treament arm

    The overall survival is defined as the time from the date of first treatment administration to date of death

    Measured: During all the study

  5. To assess the safety profile and tolerability in each treatment arm

    Safety parameters include adverse events and haematology and blood chemistry assays.

    Safety evaluations will include characterization of the frequency and severity of adverse events, complete blood cell counts with differential, serum chemistries and electrolytes, and change in weight and body surface area (BSA).

    Measured: During all the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2018
  4. Study completionMay 2019

Resources

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355445
Sponsor's protocol ID
VIT-0910
Other IDs
2010-023135-42
Acronym
VIT-0910
Status last verified
Sep 2019
First submitted
16 May 2011
Last updated
18 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3.

    PubMed 34343032

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vincristine, Irinotecan and Vincristine, Irinotecan, Temozolomide in people with RHABDOMYOSARCOMA, run by Centre Oscar Lambret at 16 sites in France.

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 39 inclusion and 0 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: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumour response and progression in each treatment arm. (time frame: at least 6 weeks (two cycles of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355445, which also lists 1 linked publication.

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 18 Sep 2019.

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