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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Centre Oscar Lambret
Sponsor:
Collaborator:
SFCE
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01355445
First received: May 16, 2011
Last updated: July 19, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
RHABDOMYOSARCOMA Drug: Vincristine, Irinotecan Drug: Vincristine, Irinotecan, Temozolomide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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).



Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

Inclusion Criteria:

  • 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
    • 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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355445

Contacts
Contact: Alicia PROBST, PhD a-probst@o-lambret.fr
Contact: Anne-Sophie DEFACHELLES, MD as-defachelles@o-lambret.fr

Locations
France
Centre Hospitalier Universitaire Nord Recruiting
Amiens, France, 80000
Contact: Alicia PLAYE         
Principal Investigator: Catherine DEVOLDERE, MD         
Hôpital des Enfants, Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Maria MERCHED         
Principal Investigator: Cécile VERITE-GOULARD, MD         
CHU Morvan Recruiting
Brest, France
Contact: Typhaine THOMAS         
Principal Investigator: Philippe LE MOINE, MD         
CHU Estaing Suspended
Clermont ferrand, France, 63003
Centre Oscar Lambret Recruiting
Lille cedex, France, 59020
Contact: Pauline SMIS         
Contact: Maddalena CHEVALIER         
Principal Investigator: Anne-Sophie DEFACHELLES, MD         
Sub-Investigator: Pierre LEBLOND, MD         
Sub-Investigator: Cyril LERVAT, MD         
Sub-Investigator: Hélène SUDOUR, MD         
Sub-Investigator: Nicolas PENEL, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Cécile GIRAUD         
Principal Investigator: Christophe BERGERON, MD         
CHU, Hôpital d'Enfants de la Timone Recruiting
Marseille, France
Contact: Sylvie ABED         
Principal Investigator: Jean-Claude GENTET, MD         
Hôpital Arnaud de Villeneuve - CHU Suspended
Montpellier, France
CHU, Hôpital Mère enfants Recruiting
Nantes, France
Contact: Estelle THEBAUD         
Principal Investigator: Sophie DUMOUCEL, MD         
Hôpital Armand Trousseau Recruiting
Paris, France
Contact: Audrey GUILMATRE         
Principal Investigator: Guy LEVERGER, MD         
Institut Curie Recruiting
Paris, France
Contact: Soraya DIB         
Principal Investigator: Daniel ORBACH, MD         
Hôpital Jean Bernard Recruiting
Poitiers, France
Contact: Violaine GOYEAU         
Principal Investigator: Frédéric MILLOT, MD         
CHU - Hôpital Américain Suspended
Reims, France
CHU Rennes - Hôpital Sud Recruiting
Rennes, France
Contact: Isabelle DEBROISE         
Principal Investigator: Sophie TAQUE, MD         
CHU St Etienne - Hôpital Nord Recruiting
Saint-Etienne, France
Contact: Catherine SOLER         
Principal Investigator: Claire BERGER, MD         
Hôpital de Hautepierre Suspended
Strasbourg, France
Hôpital des enfants Recruiting
Toulouse, France
Contact: Gwennaëlle ALPHONSA         
Principal Investigator: Marie-Pierre CASTEX, MD         
CHRU Suspended
Tours, France
CHRU Hôpital d'Enfants Recruiting
Vandoeuvre les Nancy, France
Contact: Sandrine PALL-KONDOLFF         
Principal Investigator: Pascal CHASTAGNER, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Laurence TARTIER         
Contact: Imène HEZAM         
Principal Investigator: Véronique MINARD-COLIN, MD         
Sponsors and Collaborators
Centre Oscar Lambret
SFCE
Investigators
Principal Investigator: Anne-Sophie DEFACHELLES, MD Centre Ocsar Lambet, 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
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01355445     History of Changes
Other Study ID Numbers: VIT-0910
2010-023135-42 ( EudraCT Number )
Study First Received: May 16, 2011
Last Updated: July 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Irinotecan
Camptothecin
Vincristine
Temozolomide
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 16, 2017