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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT00918320
• Date of registration: 08/06/2009
• Prospective Registration: No
• Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Public title: Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours TOTEM2
• Scientific title: Phase 2 Single- Arm Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Neuroblastoma and Other Paediatric Solid Tumours
• Date of first enrolment: June 2009
• Target sample size: 129
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00918320
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Birgit Geoerger, MD, PHD
• Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Key inclusion & exclusion criteria

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.



Age minimum: 6 Months
Age maximum: 20 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Brain Tumors

Neuroblastoma

Solid Tumors

Intervention(s)

Drug: Temozolomide/Hycamtin (Topotecan)

Primary Outcome(s)

Response rate [Time Frame: after 2 cycles=8 weeks of therapy]

Secondary Outcome(s)

safety and adverse event profile of the combination safety and adverse event [Time Frame: 28 days]

time-to-event endpoints: duration of response, time to progressive disease, time to treatment failure and overall survival [Time Frame: every 8 weeks]

Secondary ID(s)

CSET 2008/1378

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Erasmus Medical Center

Catholic University of the Sacred Heart

St. Anna Kinderkrebsforschung