Clinical trial NCT01288573 (phase 1/phase 2, status: completed)
Conditions: ewing's sarcoma/soft tissue sarcoma, neuroblastoma, brain tumors
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6
Drugs: plerixafor, plerixafor, plerixafor
SMILES: C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1, C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1, C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1
Eligibility criteria:

        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