Clinical Trial Details
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NCT01288573 : A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone
PhasePhase 1/Phase 2
AgesMin: 1 Year Max: 18 Years
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

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

- 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

- The patient (and/or their parent/legal guardian), in the opinion of the Investigator,
is unable to adhere to the requirements of the study
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