Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors (ASCR)

  • STATUS
    Recruiting
  • End date
    Nov 23, 2022
  • participants needed
    20
  • sponsor
    Washington University School of Medicine
Updated on 30 April 2022
renal function
cancer
edema
corticosteroids
stem cell transplantation
cyclophosphamide
lymphoma
ejection fraction
ependymoma
growth factor
karnofsky performance status
shortening fraction
glomerular filtration rate
schwartz
kidney function tests
neutrophil count
pulse oximetry
thalidomide
cancer chemotherapy
solid tumor
sarcoma
ewing's sarcoma
medulloblastoma
dyspnea at rest
irregular bleeding
peripheral neuroepithelioma
primitive neuroectodermal tumor
left ventricular fractional shortening
gliomas
wilms' tumor
thalomid

Summary

The purpose of this research study is to determine whether taking either of two low dose drugs that would prevent new blood vessels from growing after stem cell transplant is feasible, and what the side effects of taking each of these drugs after autologous transplant might be. The reason the investigators are looking at these drugs is because one of the things that allows tumors to grow quickly is their ability to stimulate the growth of new blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the investigators hope to prevent the tumors from coming back or continuing to grow.

Details
Condition Glioma, Neuroectodermal Tumors, Primitive, Wilms Tumor, Rhabdomyosarcoma, Sarcoma, Ewing, Osteosarcoma, Retinoblastoma
Treatment thalidomide, Metronomic Cyclophosphamide
Clinical Study IdentifierNCT01661400
SponsorWashington University School of Medicine
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
Prior radiation therapy and/or chemotherapy, including cyclophosphamide, are permitted
study enrollment, with adequate supply defined as 3 x 10^6 CD34+ cells/kg for
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted
peripheral blood stem cells (PBSC). Cell mobilization method will be left up
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
to the treating physician's discretion and may include mobilization growth
Patient must have a life expectancy > 3 months
factor alone or mobilization after chemotherapy. If patient is unable to
Patient must have an adequate bone marrow reserve as defined by
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
^8 mononuclear cells/kg will be considered adequate. If necessary, a
combination of peripheral stem cells and bone marrow can be used
Pulse oximetry > 94% on room air or O2 by nasal cannula and
No evidence of dyspnea at rest
Hemoglobin ≥ 8.0 g/dl and
Patient must have adequate hepatic function as defined by
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
Patient must have adequate cardiac function tested within 4 weeks of study enrollment
Patient must have adequate renal function as defined by
as defined by
Serum creatinine < 1.5 mg/dl
Shortening fraction of ≥ 27% by echocardiogram or
Ejection fraction of ≥ 50% by radionuclide angiogram
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 adequate pulmonary function tested within 4 weeks of study
Enrollment in the Celgene THALOMID REMSTM Program
enrollment as defined by
If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMSTM Program prior to day +30 post-ASCR
If enrolled in Arm III of this study, patient must be willing to practice birth control as outlined in the THALOMID REMSTM Program from the beginning of the thalidomide treatment 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
Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age and
effective method or two barrier methods must be used at the same time
SGOT (AST) or SGPT (ALT) ≤ 2.5 x ULN (SGOT ≤ 4x ULN if on Zantac)
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
Pregnancy surveillance
Patient must have a negative in office pregnancy test sensitive to within 50 mIU/mL (serum or urine) within 24 hours prior to beginning thalidomide even if continuous abstinence is the preferred method of birth control. ii. 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 iii. Negative pregnancy tests are valid for only 7 days. iv. If irregular bleeding or skipped menses, pregnancy test should be performed and pregnancy counseling given. v. 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
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