Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01661400
Other study ID # 201209088
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 26, 2012
Est. completion date December 27, 2023

Study information

Verified date January 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 27, 2023
Est. primary completion date December 27, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 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 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. - 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 - Enrollment in the Celgene THALOMID REMSTM Program: 1. If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMSTM Program prior to day +30 post-ASCR. 2. 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 effective method or two barrier methods must be used at the same time. 3. Pregnancy surveillance: i. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metronomic Cyclophosphamide

Thalidomide


Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as measured by absence of grade 4 or 5 non-hematological or grade 5 hematological toxicity Through 1 year post-transplant
Primary Incidence of major transplant related toxicities (Grades IV and IV) Within the first year of transplant
Secondary Best overall response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. 86 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2