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

NCT00918320 | Completed Phase 2 DMC

• 1 other identifier: CSET 2008/1378
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroblastoma; Brain Tumors; Solid Tumors

Keywords

Temozolomide; Topotecan; paediatric solid tumours; Miscellaneous other solid tumours

Outcome Measures

Primary Outcomes (1)

• Response rate

  after 2 cycles=8 weeks of therapy

Secondary Outcomes (2)

• safety and adverse event profile of the combination safety and adverse event

  28 days

• time-to-event endpoints: duration of response, time to progressive disease, time to treatment failure and overall survival

  every 8 weeks

Study Arms (1)

Toptecan + temozolomide

EXPERIMENTAL

Drug: Temozolomide/Hycamtin (Topotecan)

Interventions

Temozolomide/Hycamtin (Topotecan) DRUG

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

Also known as: Hycamtin:Topotecan

Toptecan + temozolomide

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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:
• year: ≤ 40 µmol/L
• years: ≤ 65 µmol/L
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• St. Anna Kinderkrebsforschung: collaborator
• Catholic University of the Sacred Heart: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neuroblastoma; Brain Neoplasms

Interventions

Temozolomide; Topotecan

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Birgit Geoerger, MD, PHD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

FR (1)