- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355445
Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma (VIT-0910)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Amiens, France
- CHU d'Amiens Picardie Site Sud
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Bordeaux, France
- Hôpital des Enfants, Groupe Hospitalier Pellegrin
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Lille cedex, France
- Centre Oscar Lambret
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Lyon, France
- Centre Leon Berard
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Marseille, France
- CHU, Hôpital d'Enfants de la Timone
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Montpellier, France
- Hôpital Arnaud de Villeneuve - CHU
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Nantes, France
- CHU, Hôpital Mère enfants
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Paris, France
- Institut Curie
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Paris, France
- Hopital Armand Trousseau
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Poitiers, France
- Hopital Jean Bernard
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Rennes, France
- CHU Rennes - Hôpital sud
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Saint-Etienne, France
- CHU St Etienne - Hôpital Nord
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Toulouse, France
- Hôpital Des Enfants
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Tours, France
- CHRU
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Vandoeuvre les Nancy, France
- CHRU Hôpital d'Enfants
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Villejuif, France
- Institut Gustave Roussy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Vincristine / Irinotecan
Vincristine, Irinotecan Vincristine :1.5 mg/m² (max 2mg), IV Irinotecan : Irinotecan 50 mg/m²/d, IV
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Other Names:
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Experimental: Vincristine / Irinotecan / Temozolomide
Vincristine, Irinotecan, Temozolomide
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective tumour response and progression in each treatment arm.
Time Frame: at least 6 weeks (two cycles of treatment)
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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.
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at least 6 weeks (two cycles of treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the duration of tumor response in each treatment arm
Time Frame: During all the study
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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
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During all the study
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To determine the time to tumor progression in each treatment arm
Time Frame: During all the study
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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
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During all the study
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To assess the time to treatment failure in each treatment arm
Time Frame: Before 1 year
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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
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Before 1 year
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To assess the overall survival in each treament arm
Time Frame: During all the study
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The overall survival is defined as the time from the date of first treatment administration to date of death
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During all the study
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To assess the safety profile and tolerability in each treatment arm
Time Frame: During all the study
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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). |
During all the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Myosarcoma
- Rhabdomyosarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Temozolomide
- Irinotecan
- Vincristine
Other Study ID Numbers
- VIT-0910
- 2010-023135-42 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on RHABDOMYOSARCOMA
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Children's Oncology GroupNational Cancer Institute (NCI)RecruitingAlveolar Rhabdomyosarcoma | Embryonal Rhabdomyosarcoma | Botryoid-Type Embryonal Rhabdomyosarcoma | Spindle Cell Rhabdomyosarcoma | Spindle Cell/Sclerosing Rhabdomyosarcoma | Metastatic Embryonal Rhabdomyosarcoma | Metastatic Rhabdomyosarcoma | Solid Alveolar RhabdomyosarcomaUnited States, Canada, Australia, Puerto Rico, Saudi Arabia
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Embryonal-botryoid Childhood RhabdomyosarcomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Adult Soft Tissue Sarcoma | Adult Rhabdomyosarcoma | Metastatic Childhood Soft Tissue Sarcoma | Childhood Alveolar Rhabdomyosarcoma | Childhood Embryonal Rhabdomyosarcoma | Untreated Childhood RhabdomyosarcomaUnited States, Canada, Australia, New Zealand
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood RhabdomyosarcomaUnited States
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National Cancer Institute (NCI)Active, not recruitingRhabdomyosarcoma | Alveolar Rhabdomyosarcoma | Embryonal Rhabdomyosarcoma | Botryoid-Type Embryonal Rhabdomyosarcoma | Sclerosing Rhabdomyosarcoma | Spindle Cell RhabdomyosarcomaUnited States, Canada, Puerto Rico, Australia, New Zealand
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National Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Recurrent Adult Soft Tissue Sarcoma | Previously Treated Childhood Rhabdomyosarcoma | Adult Rhabdomyosarcoma | Childhood Alveolar Rhabdomyosarcoma | Childhood Pleomorphic Rhabdomyosarcoma | Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar FeaturesUnited States, Canada, Australia, New Zealand
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Children's Oncology GroupNational Cancer Institute (NCI)RecruitingEmbryonal Rhabdomyosarcoma | Fusion-Negative Alveolar Rhabdomyosarcoma | Spindle Cell/Sclerosing RhabdomyosarcomaUnited States, Australia, Canada, New Zealand
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdult Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Embryonal-botryoid Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States
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University of Texas Southwestern Medical CenterRecruitingSolid Tumor | RhabdomyosarcomaUnited States
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ECOG-ACRIN Cancer Research GroupRecruitingRecurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | Lymphoblasts 5 Percent or More of Bone Marrow Nucleated CellsUnited States
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