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Sponsor: Genzyme, a Sanofi Company
Conditions: Ewing's Sarcoma/Soft Tissue Sarcoma, Neuroblastoma, Brain Tumors
Interventions: plerixafor, plerixafor, plerixafor
Countries: Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy
This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: * Stage 1 is a dose-escalation study. * Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study. All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative). Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.
Sex: ALL
Age: 1 Year to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age 2 to \< 18 years during stage 1 and 1 to \< 18 years during stage 2 * Ewing's sarcoma, soft tissue sarcoma, lymphoma, neuroblastoma, brain tumors or other malignancy (excluding any form of leukemia) requiring treatment with high dose chemotherapy and autologous transplant as rescue therapy * Eligible for autologous transplantation * Recovered from all acute significant toxic effects of prior chemotherapy * Adequate performance status (for patients ≥16 years of age, defined as Karnofsky score \>60 and for patients \<16 years of age, defined as Lansky score \>60) * Absolute neutrophil count \>0.75 × 10\^9/L * Platelet count \>50 × 10\^9/L * Calculated creatinine clearance (using the Schwartz method): during study Stage 1, \>80 mL/min/1.73m\^2 and during study Stage 2, \>60 mL/min/1.73m\^2 * Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase(SGOT), alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<3 × upper limit of normal * The patient and/or their parent/legal guardian is willing and able to provide signed informed consent * Patients who are sexually active must be willing to abstain from sexual intercourse or agree to use an approved form of contraception while receiving plerixafor and/or standard mobilization treatment and for at least 3 months following any plerixafor treatment Exclusion Criteria: * Any form of leukemia * A co-morbid condition which, in the view of the Investigator, renders the patient at high-risk from treatment complications * Previous stem cell transplantation * Persistent high percentage marrow involvement prior to mobilization will be prohibited. * On-going toxicities (excluding alopecia) Grade ≥2 resulting from prior chemotherapy * Acute infection * Fever (temperature \>38.5°C) - if fever is between 37°C and 38.5°C, infection must be excluded as a cause * Known HIV seropositivity, AIDS, hepatitis C or active hepatitis B infections * Positive pregnancy test in post pubertal girls * History of clinically significant cardiac abnormality or arrhythmia * Use of an investigational drug which is not approved in any indication either in adults or pediatrics within 2 weeks prior to the first dose of G-CSF to be administered as part of the patient's planned standard mobilization regimen, and/or during the study up until engraftment of the transplant. If patients are on investigational drugs as part of their anti-cancer regimen, this should be discussed with the Sponsor before screening. Drugs approved for other indications that are being used in a manner considered standard of care for this transplant procedure are allowed * The patient (and/or their parent/legal guardian), in the opinion of the Investigator, is unable to adhere to the requirements of the study
- Ghent, Belgium
- Brno, Czechia
- Praha 5 - Motol, Czechia
- København Ø, Denmark
- Lyon, France
- Paris, France
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Hanover, Germany
- München, Germany
- Budapest, Hungary
- Petah Tikva, Israel
- Tel Aviv, Israel
- Genova, Italy
- Milan, Italy
- Padova, Italy
- Roma, Italy
- Torino, Italy
- Amsterdam, Netherlands
- Rotterdam, Netherlands
- Krakow, Poland
- Wroclaw, Poland
- Barcelona, Spain
- Madrid, Spain
- Birmingham, United Kingdom
- Glasgow, United Kingdom