Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01661400 : Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors
PhaseEarly Phase 1
AgesMin: 6 Months Max: 21 Years
Eligibility
Inclusion Criteria:

- Patient must have an original diagnosis, benefited by autologous transplantation,
confirmed by biopsy* of high-grade glial tumor, low-grade glial tumor, ependymoma,
medulloblastoma, primitive neuro-ectodermal tumor (PNET), Wilms' tumor,
rhabdomyosarcoma, Ewing's sarcoma, retinoblastoma, or miscellaneous poor-prognosis
solid tumors. Lymphomas and other lymphoid malignancies will not be studied in this
protocol.

* Brain stem glioma patients who have progressed after radiation therapy do not
require histologic confirmation. Brain stem gliomas are defined as intrinsic tumors of
the pons causing diffuse enlargement. These patients are diagnosed on clinical and
radiographic appearance of the lesion and the biopsy requirement will be waived for
this group.

- Patient must be = 6 months of age and = 21 years of age at the time of study entry.

- Patient must have a Karnofsky performance status or Lansky* play status = 50

* For purpose of determining performance scores, wheelchair-bound patients will be
considered ambulatory.

- Patient must have an adequate supply of stem cells for transplant harvested prior to
study enrollment, with adequate supply defined as 3 x 106 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 108 mononuclear cells/kg will be considered
adequate. If necessary, a combination of peripheral stem cells and bone marrow can be
used.

- 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.

- Patient must have a life expectancy > 3 months.

- Patient must have an adequate bone marrow reserve as defined by:

- Hemoglobin = 8.0 g/dl and

- Peripheral absolute neutrophil count (ANC) = 750/mm3

- Patient must have adequate cardiac function tested within 4 weeks of study enrollment
as defined by:

- Shortening fraction of = 27% by echocardiogram or

- Ejection fraction of = 50% by radionuclide angiogram

- Patient must have adequate pulmonary function tested within 4 weeks of study
enrollment as defined by:

- Pulse oximetry > 94% on room air or O2 by nasal cannula and

- No evidence of dyspnea at rest.

- Patient must have adequate hepatic function as defined by:

- Total bilirubin = 1.5x upper limit of normal (ULN) for age and

- SGOT (AST) or SGPT (ALT) = 2.5 x ULN (SGOT = 4x ULN if on Zantac)

- Patient must have adequate renal function as defined by:

- Serum creatinine < 1.5 mg/dl

- 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

- If female of childbearing potential (defined as menstruating or amenorrheic from
previous medical treatments), the following guidelines must be adhered to:

- If enrolled in Arm III of this study, patient must be registered at the Celgene
S.T.E.P.S. ® Program.

- If enrolled in Arm III of this study, patient must be willing to practice birth
control as outlined in the S.T.E.P.S. Program from the beginning of the study
until at least 4 weeks following discontinuation of thalidomide therapy. Two
reliable forms of contraception must be used simultaneously unless continuous
abstinence from heterosexual sexual contact is chosen. Contraceptive methods must
include at least one highly effective method (e.g. oral contraceptive pills,
injections, hormonal patches, IUD, or implants), AND one additional effective
barrier method (e.g. latex condom, diaphragm, cervical cap). If hormonal or IUD
contraception is medically contraindicated, another highly effective method or
two barrier methods must be used at the same time.

- Pregnancy surveillance:

- Patient must have a negative in office pregnancy test sensitive to within 50
mIU/mL (serum or urine) within 24 hours of beginning thalidomide even if
continuous abstinence is the preferred method of birth control.

- A pregnancy test must be performed weekly during the first 4 weeks of therapy and
repeated monthly for patients with regular menses or every 2 weeks for patients
with irregular menses

- Negative pregnancy tests are valid for only 7 days.

- If irregular bleeding or skipped menses, pregnancy test should be performed and
pregnancy counseling given.

- If pregnancy occurs during treatment, thalidomide must be immediately
discontinued. Any suspected lethal exposure must be reported immediately to
Celgene Customer Care Center at 1-888-423-5346, and the patient referred to an
OB/GYN experienced in reproductive toxicity for further evaluation and
counseling.

- Patient (or legally authorized representative) must be able to understand and willing
to sign a written informed consent document.

Exclusion Criteria:

- 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 be receiving any other investigational agents.

- Patient must not have any active infection or concurrent illness obscuring toxicity or
dangerously altering drug metabolism.

- Patient must not have any thromboembolic event (deep vein thrombosis or pulmonary
embolism) less than 3 weeks prior to enrollment.

- 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 be pregnant or breastfeeding.

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.
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