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Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma (VIT-0910)

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ClinicalTrials.gov Identifier: NCT01355445
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : September 18, 2019
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief 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.

Condition or disease Intervention/treatment Phase
RHABDOMYOSARCOMA Drug: Vincristine, Irinotecan Drug: Vincristine, Irinotecan, Temozolomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: Vincristine / Irinotecan
Vincristine, Irinotecan Vincristine :1.5 mg/m² (max 2mg), IV Irinotecan : Irinotecan 50 mg/m²/d, IV
Drug: 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
Other Name: Vincristine-Irinotecan

Experimental: Vincristine / Irinotecan / Temozolomide
Vincristine, Irinotecan, Temozolomide
Drug: 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
Other Name: Vincristine-Irinotecan-Temozolomide

Primary Outcome Measures :
  1. Objective tumour response and progression in each treatment arm. [ Time Frame: at least 6 weeks (two cycles of treatment) ]
    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.

Secondary Outcome Measures :
  1. To assess the duration of tumor response in each treatment arm [ Time Frame: During all the study ]
    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

  2. To determine the time to tumor progression in each treatment arm [ Time Frame: During all the study ]
    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

  3. To assess the time to treatment failure in each treatment arm [ Time Frame: Before 1 year ]
    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

  4. To assess the overall survival in each treament arm [ Time Frame: During all the study ]
    The overall survival is defined as the time from the date of first treatment administration to date of death

  5. To assess the safety profile and tolerability in each treatment arm [ Time Frame: During all the study ]

    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


    • 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

    • Age > 6 months and ≤ 50 years
    • 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

    • 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

Exclusion Criteria:

  • Inclusion criteria failure
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355445

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CHU d'Amiens Picardie Site Sud
Amiens, France
Hôpital des Enfants, Groupe Hospitalier Pellegrin
Bordeaux, France
Centre Oscar Lambret
Lille cedex, France
Centre Léon Bérard
Lyon, France
CHU, Hôpital d'Enfants de la Timone
Marseille, France
Hôpital Arnaud de Villeneuve - CHU
Montpellier, France
CHU, Hôpital Mère enfants
Nantes, France
Hôpital Armand Trousseau
Paris, France
Institut Curie
Paris, France
Hôpital Jean Bernard
Poitiers, France
CHU Rennes - Hôpital Sud
Rennes, France
CHU St Etienne - Hôpital Nord
Saint-Etienne, France
Hôpital des enfants
Toulouse, France
Tours, France
CHRU Hôpital d'Enfants
Vandoeuvre les Nancy, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Centre Oscar Lambret
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Principal Investigator: Anne-Sophie DEFACHELLES, MD Centre Ocsar Lambret, Lille, France
Principal Investigator: Julia CHISHOLM, MD Royal Marsden NHS Foundation Trust, Surrey, Uinted Kingdom
Principal Investigator: J.H.M. MD MERKS Emma Children's Hospital, Amsterdam, The Netherlands
Principal Investigator: Michela CASANOVA, MD Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy
Principal Investigator: Soledad GALLEGO, MDn Hospital Materno - Infantil Vall D' Hebron, Barcelona, Spain
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01355445    
Other Study ID Numbers: VIT-0910
2010-023135-42 ( EudraCT Number )
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents