Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
18

Inclusion Criteria

No evidence of dyspnea at rest.
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age and
Ejection fraction of ≥ 50% by radionuclide angiogram
...
No evidence of dyspnea at rest.
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age and
Ejection fraction of ≥ 50% by radionuclide angiogram
Serum creatinine < 1.5 mg/dl
Shortening fraction of ≥ 27% by echocardiogram or
SGOT (AST) or SGPT (ALT) ≤ 2.5 x ULN (SGOT ≤ 4x ULN if on Zantac)
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
Pulse oximetry > 94% on room air or O2 by nasal cannula and
Glomerular filtration rate (GFR), calculated via I-125 iothalamate clearance, 24-hour creatinine clearance, or Schwartz formula*, ≥ 70 mL/min and ≥ 50 mL/min/1.73 m2 done within 4 weeks of study entry
The Schwartz formula is an estimated glomerular filtration rate in children based upon serum creatinine and height. Height (Ht) should be measured in cm and serum creatinine (Cr) in mg/dL. Proportionality constant (k) is 0.55 for children and adolescent girls and 0.7 for adolescent boys aged 13-21. This constant is based upon a series of evaluations performed by Schwartz. Formula: GFR= (k x Ht)/Cr
Patient must have a life expectancy > 3 months.
Prior radiation therapy and/or chemotherapy, including cyclophosphamide, are permitted.
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted.
If on corticosteroids for mass effect and/or edema related to the tumor, patient must be on a stable or decreasing dose for at least 2 weeks prior to study entry.
Hemoglobin ≥ 8.0 g/dl and
Patient must have an adequate supply of stem cells for transplant harvested prior to study enrollment, with adequate supply defined as 3 x 10^6 CD34+ cells/kg for peripheral blood stem cells (PBSC). Cell mobilization method will be left up to the treating physician's discretion and may include mobilization growth factor alone or mobilization after chemotherapy. If patient is unable to mobilize the proper amount of peripheral stem cells, bone marrow may be harvested as the source of hematopoietic stem cells. In this instance, 3 x 10^8 mononuclear cells/kg will be considered adequate. If necessary, a combination of peripheral stem cells and bone marrow can be used.
If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMSTM Program prior to day +30 post-ASCR.
Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Patient must be ≥ 6 months of age and ≤ 21 years of age at the time of study entry.
Pregnancy surveillance:

Exclusion Criteria

Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Patient must not have any active infection or concurrent illness obscuring toxicity or dangerously altering drug metabolism.
...
Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Patient must not have any active infection or concurrent illness obscuring toxicity or dangerously altering drug metabolism.
Patient must not be pregnant or breastfeeding.
Patient must not have any thromboembolic event (deep vein thrombosis or pulmonary embolism) less than 3 weeks prior to enrollment.
Patient must not be receiving any other investigational agents.

Summary

Conditions
  • Glioma
  • Neuroectodermal Tumors, Primitive
  • Osteosarcoma
  • Retinoblastoma
  • Rhabdomyosarcoma
  • Sarcoma, Ewing
  • Wilm's Tumor
  • Wilms Tumor
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 621 years
Gender
Both males and females

Inclusion Criteria

No evidence of dyspnea at rest.
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age and
Ejection fraction of ≥ 50% by radionuclide angiogram
...
No evidence of dyspnea at rest.
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age and
Ejection fraction of ≥ 50% by radionuclide angiogram
Serum creatinine < 1.5 mg/dl
Shortening fraction of ≥ 27% by echocardiogram or
SGOT (AST) or SGPT (ALT) ≤ 2.5 x ULN (SGOT ≤ 4x ULN if on Zantac)
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
Pulse oximetry > 94% on room air or O2 by nasal cannula and
Glomerular filtration rate (GFR), calculated via I-125 iothalamate clearance, 24-hour creatinine clearance, or Schwartz formula*, ≥ 70 mL/min and ≥ 50 mL/min/1.73 m2 done within 4 weeks of study entry
The Schwartz formula is an estimated glomerular filtration rate in children based upon serum creatinine and height. Height (Ht) should be measured in cm and serum creatinine (Cr) in mg/dL. Proportionality constant (k) is 0.55 for children and adolescent girls and 0.7 for adolescent boys aged 13-21. This constant is based upon a series of evaluations performed by Schwartz. Formula: GFR= (k x Ht)/Cr
Patient must have a life expectancy > 3 months.
Prior radiation therapy and/or chemotherapy, including cyclophosphamide, are permitted.
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted.
If on corticosteroids for mass effect and/or edema related to the tumor, patient must be on a stable or decreasing dose for at least 2 weeks prior to study entry.
Hemoglobin ≥ 8.0 g/dl and
Patient must have an adequate supply of stem cells for transplant harvested prior to study enrollment, with adequate supply defined as 3 x 10^6 CD34+ cells/kg for peripheral blood stem cells (PBSC). Cell mobilization method will be left up to the treating physician's discretion and may include mobilization growth factor alone or mobilization after chemotherapy. If patient is unable to mobilize the proper amount of peripheral stem cells, bone marrow may be harvested as the source of hematopoietic stem cells. In this instance, 3 x 10^8 mononuclear cells/kg will be considered adequate. If necessary, a combination of peripheral stem cells and bone marrow can be used.
If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMSTM Program prior to day +30 post-ASCR.
Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Patient must be ≥ 6 months of age and ≤ 21 years of age at the time of study entry.
Pregnancy surveillance:

Exclusion Criteria

Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Patient must not have any active infection or concurrent illness obscuring toxicity or dangerously altering drug metabolism.
...
Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Patient must not have any active infection or concurrent illness obscuring toxicity or dangerously altering drug metabolism.
Patient must not be pregnant or breastfeeding.
Patient must not have any thromboembolic event (deep vein thrombosis or pulmonary embolism) less than 3 weeks prior to enrollment.
Patient must not be receiving any other investigational agents.

Tracking Information

NCT #
NCT01661400
Collaborators
Not Provided
Investigators
  • Principal Investigator: Andrew Cluster, M.D. Washington University School of Medicine
  • Andrew Cluster, M.D. Washington University School of Medicine
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