Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours (TOTEM2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
St. Anna Kinderkrebsforschung
Catholic University of the Sacred Heart
Erasmus Medical Center
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: June 8, 2009
Last updated: June 10, 2009
Last verified: June 2009

The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.

Condition Intervention Phase
Brain Tumors
Solid Tumors
Drug: Temozolomide/Hycamtin (Topotecan)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Single- Arm Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Neuroblastoma and Other Paediatric Solid Tumours

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Response rate [ Time Frame: after 2 cycles=8 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and adverse event profile of the combination safety and adverse event [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • time-to-event endpoints: duration of response, time to progressive disease, time to treatment failure and overall survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 93
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Temozolomide/Hycamtin (Topotecan)

    Temozolomide: bottles containing 5 capsules of 5, 20, 100 and 250 mg

    Hycamtin (Topotecan): a lyophilisate for infusion in vials containing 4 mg

    Patients receive during 5 days (Day 1 to Day 5):

    Temozolomide 150 mg/m2/day per os, dose will be adjusted to the closest 5 mg, followed one hour later by Hycamtin(Topotecan) 0.75 mg/m2/day as an intravenous infusion over 30 minutes

    Other Name: Hycamtin:Topotecan
  Show Detailed Description


Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis)
  • Relapsed or refractory tumors in which correct standard treatment approaches have failed
  • No more than 2 lines of prior chemotherapy
  • Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion.

For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring.

  • Age at inclusion: 6 months to ≤ 20 years
  • Lansky play score ≥ 70% or ECOG performance status ≤ 1
  • Life expectancy ≥ 3 months
  • Adequate organ function:

Adequate haematological function: haemoglobin ≥ 80 g/l, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/l and platelets ≥ 75 x 109/l;

Adequate renal function: normal creatinine related to patient's age:

  • 0 - 1 year: ≤ 40 µmol/L
  • 1 - 15 years: ≤ 65 µmol/L
  • 15 - 20 years: ≤ 110 µmol/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤5xULN in case of liver metastases)

    • Wash-out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study.
    • Patients previously treated with only one of the 2 drugs are eligible.
    • Able to comply with scheduled follow-up and with management of toxicity.
    • All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment.
    • Written informed consent from patient, parents or legal guardian.

Exclusion Criteria:

  • Concurrent administration of any other anti-tumour therapy.
  • Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • History of allergic reaction to the compounds or their solvents.
  • History of allergic reaction to Dacarbazine (DITC).
  • Galactosemia, Glucose-galactose malabsorption or lactase deficiency.
  • Pregnant or breast feeding young women.
  • Presence of symptomatic brain metastases in patients with solid non-CNS tumors.
  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 identifier: NCT00918320

Contact: Birgit Geoerger, MD, PHD 00 331 42 11 62 61

Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Principal Investigator: Birgit Geoerger, MD, PHD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
St. Anna Kinderkrebsforschung
Catholic University of the Sacred Heart
Erasmus Medical Center
Principal Investigator: Birgit Geoerger, MD, PHD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Birgit Geoerger, Institut Gustave Roussy Identifier: NCT00918320     History of Changes
Other Study ID Numbers: CSET 2008/1378
Study First Received: June 8, 2009
Last Updated: June 10, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Federal Office for Safety in Health Care
Italy: National Institute of Health
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
paediatric solid tumours
Miscellaneous other solid tumours

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on March 03, 2015