ClinicalTrials.gov

History of Changes for Study: NCT03213665
Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations
Latest version (submitted June 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 10, 2017 None (earliest Version on record)
2 July 18, 2017 Study Status
3 July 27, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 July 28, 2017 Study Status and Study Identification
5 August 8, 2017 Contacts/Locations and Study Status
6 August 14, 2017 Arms and Interventions, Conditions and Study Status
7 August 21, 2017 Contacts/Locations and Study Status
8 August 23, 2017 Contacts/Locations and Study Status
9 September 1, 2017 Contacts/Locations and Study Status
10 September 4, 2017 Contacts/Locations, Arms and Interventions and Study Status
11 September 18, 2017 Contacts/Locations and Study Status
12 September 21, 2017 Contacts/Locations and Study Status
13 September 22, 2017 Contacts/Locations and Study Status
14 September 25, 2017 Contacts/Locations and Study Status
15 September 28, 2017 Study Status
16 October 3, 2017 Contacts/Locations and Study Status
17 October 6, 2017 Contacts/Locations and Study Status
18 October 12, 2017 Contacts/Locations and Study Status
19 October 13, 2017 Contacts/Locations and Study Status
20 October 19, 2017 Contacts/Locations and Study Status
21 October 23, 2017 Contacts/Locations and Study Status
22 October 25, 2017 Contacts/Locations and Study Status
23 October 27, 2017 Contacts/Locations and Study Status
24 October 30, 2017 Contacts/Locations and Study Status
25 November 3, 2017 Contacts/Locations and Study Status
26 November 6, 2017 Contacts/Locations and Study Status
27 November 13, 2017 Contacts/Locations and Study Status
28 November 16, 2017 Contacts/Locations and Study Status
29 November 20, 2017 Contacts/Locations, Conditions and Study Status
30 November 30, 2017 Contacts/Locations and Study Status
31 December 4, 2017 Contacts/Locations and Study Status
32 December 7, 2017 Contacts/Locations and Study Status
33 December 8, 2017 Contacts/Locations and Study Status
34 December 11, 2017 Contacts/Locations and Study Status
35 December 13, 2017 Contacts/Locations and Study Status
36 December 14, 2017 Contacts/Locations and Study Status
37 December 18, 2017 Contacts/Locations and Study Status
38 December 20, 2017 Contacts/Locations and Study Status
39 December 21, 2017 Contacts/Locations, Conditions and Study Status
40 December 22, 2017 Conditions and Study Status
41 January 1, 2018 Contacts/Locations and Study Status
42 January 4, 2018 Contacts/Locations and Study Status
43 January 12, 2018 Contacts/Locations and Study Status
44 January 15, 2018 Contacts/Locations and Study Status
45 January 22, 2018 Contacts/Locations and Study Status
46 January 24, 2018 Contacts/Locations and Study Status
47 January 25, 2018 Contacts/Locations and Study Status
48 January 26, 2018 Contacts/Locations and Study Status
49 January 29, 2018 Contacts/Locations and Study Status
50 January 31, 2018 Contacts/Locations and Study Status
51 February 1, 2018 Contacts/Locations and Study Status
52 February 5, 2018 Contacts/Locations and Study Status
53 February 7, 2018 Contacts/Locations and Study Status
54 February 8, 2018 Contacts/Locations and Study Status
55 February 9, 2018 Contacts/Locations and Study Status
56 February 14, 2018 Contacts/Locations and Study Status
57 February 15, 2018 Contacts/Locations and Study Status
58 February 16, 2018 Contacts/Locations and Study Status
59 February 19, 2018 Contacts/Locations and Study Status
60 February 22, 2018 Contacts/Locations and Study Status
61 February 26, 2018 Contacts/Locations and Study Status
62 March 2, 2018 Contacts/Locations and Study Status
63 March 12, 2018 Contacts/Locations, Conditions and Study Status
64 March 19, 2018 Contacts/Locations and Study Status
65 March 26, 2018 Contacts/Locations and Study Status
66 March 28, 2018 Study Description, Study Status and Study Identification
67 March 29, 2018 Contacts/Locations and Study Status
68 April 2, 2018 Contacts/Locations and Study Status
69 April 12, 2018 Study Status and Contacts/Locations
70 April 16, 2018 Contacts/Locations and Study Status
71 April 18, 2018 Contacts/Locations and Study Status
72 April 25, 2018 Recruitment Status, Study Status and Contacts/Locations
73 April 26, 2018 Study Status
74 June 19, 2018 Contacts/Locations and Study Status
75 June 20, 2018 Study Status
76 June 25, 2018 Contacts/Locations and Study Status
77 June 29, 2018 Contacts/Locations and Study Status
78 July 24, 2018 Study Status
79 July 30, 2018 Study Status
80 July 31, 2018 Study Status
81 August 1, 2018 Study Status
82 August 2, 2018 Study Status
83 August 3, 2018 Contacts/Locations and Study Status
84 August 6, 2018 Study Status
85 August 30, 2018 Study Status
86 September 10, 2018 Study Status
87 September 11, 2018 Contacts/Locations and Study Status
88 September 20, 2018 Contacts/Locations and Study Status
89 October 17, 2018 Contacts/Locations and Study Status
90 October 18, 2018 Study Status
91 October 19, 2018 Study Status
92 October 31, 2018 Study Status
93 November 2, 2018 Study Status
94 November 8, 2018 Study Status
95 November 20, 2018 Study Status
96 December 18, 2018 Study Status
97 December 24, 2018 Study Status
98 February 5, 2019 Contacts/Locations and Study Status
99 February 13, 2019 Study Status
100 February 25, 2019 Study Status
101 February 27, 2019 Study Status
102 March 12, 2019 Study Status
103 March 14, 2019 Study Status
104 May 9, 2019 Study Status
105 May 10, 2019 Study Status
106 May 15, 2019 Recruitment Status, Study Status and Contacts/Locations
107 May 16, 2019 Contacts/Locations and Study Status
108 May 22, 2019 Contacts/Locations and Study Status
109 May 23, 2019 Contacts/Locations and Study Status
110 May 27, 2019 Contacts/Locations and Study Status
111 June 3, 2019 Contacts/Locations and Study Status
112 June 5, 2019 Contacts/Locations and Study Status
113 June 17, 2019 Contacts/Locations and Study Status
114 June 21, 2019 Contacts/Locations and Study Status
115 June 24, 2019 Contacts/Locations and Study Status
116 July 1, 2019 Contacts/Locations and Study Status
117 July 3, 2019 Contacts/Locations and Study Status
118 July 8, 2019 Contacts/Locations and Study Status
119 July 9, 2019 Contacts/Locations and Study Status
120 July 25, 2019 Contacts/Locations and Study Status
121 July 29, 2019 Contacts/Locations and Study Status
122 August 1, 2019 Contacts/Locations and Study Status
123 August 5, 2019 Conditions and Study Status
124 August 12, 2019 Contacts/Locations and Study Status
125 August 14, 2019 Contacts/Locations and Study Status
126 August 26, 2019 Contacts/Locations and Study Status
127 August 27, 2019 Contacts/Locations and Study Status
128 August 30, 2019 Contacts/Locations and Study Status
129 September 2, 2019 Contacts/Locations and Study Status
130 September 4, 2019 Contacts/Locations and Study Status
131 September 17, 2019 Contacts/Locations and Study Status
132 September 26, 2019 Contacts/Locations and Study Status
133 October 2, 2019 Contacts/Locations and Study Status
134 October 3, 2019 Contacts/Locations and Study Status
135 October 4, 2019 Conditions and Study Status
136 October 7, 2019 Contacts/Locations and Study Status
137 October 16, 2019 Contacts/Locations and Study Status
138 November 1, 2019 Contacts/Locations and Study Status
139 November 4, 2019 Contacts/Locations and Study Status
140 November 5, 2019 Contacts/Locations and Study Status
141 November 11, 2019 Contacts/Locations and Study Status
142 November 18, 2019 Study Status
143 November 19, 2019 Contacts/Locations and Study Status
144 November 21, 2019 Contacts/Locations and Study Status
145 November 25, 2019 Contacts/Locations and Study Status
146 November 26, 2019 Contacts/Locations and Study Status
147 January 6, 2020 Contacts/Locations and Study Status
148 January 7, 2020 Contacts/Locations and Study Status
149 January 9, 2020 Contacts/Locations and Study Status
150 January 20, 2020 Conditions and Study Status
151 January 22, 2020 Contacts/Locations and Study Status
152 January 28, 2020 Contacts/Locations and Study Status
153 February 4, 2020 Contacts/Locations and Study Status
154 February 5, 2020 Contacts/Locations and Study Status
155 February 7, 2020 Contacts/Locations and Study Status
156 February 18, 2020 Contacts/Locations and Study Status
157 February 25, 2020 Contacts/Locations and Study Status
158 February 28, 2020 Contacts/Locations and Study Status
159 March 2, 2020 Contacts/Locations and Study Status
160 March 26, 2020 Contacts/Locations and Study Status
161 April 2, 2020 Contacts/Locations and Study Status
162 April 4, 2020 Contacts/Locations and Study Status
163 April 14, 2020 Contacts/Locations, Study Status and Study Identification
164 April 22, 2020 Contacts/Locations and Study Status
165 April 29, 2020 Contacts/Locations and Study Status
166 April 30, 2020 Contacts/Locations and Study Status
167 May 2, 2020 Contacts/Locations and Study Status
168 May 14, 2020 Contacts/Locations and Study Status
169 May 16, 2020 Study Status
170 May 28, 2020 Contacts/Locations and Study Status
171 June 18, 2020 Contacts/Locations and Study Status
172 June 19, 2020 Contacts/Locations and Study Status
173 June 20, 2020 Contacts/Locations and Study Status
174 June 24, 2020 Study Status
175 June 27, 2020 Contacts/Locations and Study Status
176 July 2, 2020 Contacts/Locations and Study Status
177 July 3, 2020 Contacts/Locations and Study Status
178 July 9, 2020 Contacts/Locations and Study Status
179 July 10, 2020 Contacts/Locations and Study Status
180 July 16, 2020 Contacts/Locations and Study Status
181 July 18, 2020 Contacts/Locations and Study Status
182 July 23, 2020 Contacts/Locations and Study Status
183 July 30, 2020 Contacts/Locations and Study Status
184 August 19, 2020 Arms and Interventions, Outcome Measures, Study Description, Eligibility, Conditions, Study Status and Study Identification
185 August 27, 2020 Study Status
186 September 4, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Description
187 September 12, 2020 Sponsor/Collaborators and Study Status
188 October 14, 2020 Study Status
189 October 15, 2020 Study Status
190 October 20, 2020 Study Status
191 October 23, 2020 Study Status
192 November 20, 2020 Study Status
193 December 15, 2020 Study Status
194 December 31, 2020 Contacts/Locations and Study Status
195 February 2, 2021 Study Status
196 February 25, 2021 Study Status
197 March 5, 2021 Study Status
198 March 13, 2021 Study Status
199 April 2, 2021 Contacts/Locations and Study Status
200 May 11, 2021 Recruitment Status and Study Status
201 July 16, 2021 Study Status
202 July 20, 2021 Study Status
203 January 15, 2022 Study Status
204 April 6, 2022 Study Status and Study Design
205 April 19, 2022 Study Status
206 April 28, 2022 Contacts/Locations and Study Status
207 June 7, 2022 Arms and Interventions and Study Status
208 June 28, 2022 Arms and Interventions and Study Status
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Study NCT03213665
Submitted Date:  July 10, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCI-2017-01245
Brief Title: Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations
Official Title: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Tazemetostat in Patients With Tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex
Secondary IDs: NCI-2017-01245 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
APEC1621C [Childrens Oncology Group]
APEC1621C [CTEP]
U10CA180886 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: July 2017
Overall Status: Not yet recruiting
Study Start: August 23, 2017
Primary Completion: April 30, 2022 [Anticipated]
Study Completion: April 30, 2022 [Anticipated]
First Submitted: July 10, 2017
First Submitted that
Met QC Criteria:
July 10, 2017
First Posted: July 11, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
July 10, 2017
Last Update Posted: July 11, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Cancer Institute (NCI)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This phase II trial studies how well tazemetostat works in treating patients with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tazemetostat with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival in pediatric patients treated with tazemetostat that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4.

II. To obtain information about the tolerability of tazemetostat in children with relapsed or refractory cancer.

TERTIARY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE:

Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Open or close this module Conditions
Conditions: Advanced Malignant Solid Neoplasm
Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
EZH2 Gene Mutation
Histiocytosis
Loss of BRG1 Protein Expression
Loss of INI 1 Protein Expression
Low Grade Glioma
Malignant Glioma
Recurrent Childhood Central Nervous System Neoplasm
Recurrent Childhood Ependymoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma
Recurrent Germ Cell Tumor
Recurrent Glioma
Recurrent Hepatoblastoma
Recurrent Hodgkin Lymphoma
Recurrent Langerhans Cell Histiocytosis
Recurrent Malignant Solid Neoplasm
Recurrent Medulloblastoma
Recurrent Neuroblastoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Osteosarcoma
Recurrent Peripheral Primitive Neuroectodermal Tumor
Recurrent Rhabdomyosarcoma
Refractory Central Nervous System Neoplasm
Refractory Hodgkin Lymphoma
Refractory Langerhans Cell Histiocytosis
Refractory Malignant Germ Cell Tumor
Refractory Neuroblastoma
Refractory Non-Hodgkin Lymphoma
Rhabdoid Tumor
Stage III Childhood Hodgkin Lymphoma
Stage III Childhood Non-Hodgkin Lymphoma
Stage III Soft Tissue Sarcoma
Stage IV Childhood Hodgkin Lymphoma
Stage IV Childhood Non-Hodgkin Lymphoma
Stage IV Soft Tissue Sarcoma
Wilms Tumor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 49 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment (tazemetostat)
Patients receive tazemetostat PO BID on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis
Correlative studies
Drug: Tazemetostat
Given PO
Other Names:
  • E7438
  • EPZ-6438
  • EPZ6438
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective response rate (ORR) defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
[ Time Frame: Up to 2 years ]

Will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
Secondary Outcome Measures:
1. Progression-free survival (PFS)
[ Time Frame: From start of subprotocol treatment to time of progression or death, whichever occurs first, assessed for up to 2 years ]

PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
Other Outcome Measures:
1. Biomarker predictors of response to tazemetostat
[ Time Frame: Up to 2 years ]

Will evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.
2. Change in tumor genomics
[ Time Frame: Up to 2 years ]

To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.
Open or close this module Eligibility
Minimum Age: 12 Months
Maximum Age: 21 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621C based on the presence of an actionable mutation
  • Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease:
    • Malignant fluid collections (e.g., ascites, pleural effusions)
    • Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
    • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
    • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
    • Previously radiated lesions that have not demonstrated clear progression post radiation
    • Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
    • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive
      • >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
    • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
    • Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
    • Stem cell Infusions (with or without total body irradiation [TBI]):
      • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
      • Autologous stem cell infusion including boost infusion: >= 42 days
    • Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
    • Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
    • Patients must not have had prior exposure to tazemetostat or other inhibitor(s) of EZH2
  • For patients with solid tumors without known bone marrow involvement:
    • Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
    • Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
    • Age 1 to < 2 years: male: 0.6 mg/dL; female: 0.6 mg/dL
    • Age 2 to < 6 years: male: 0.8 mg/dL; female: 0.8 mg/dL
    • Age 6 to < 10 years: male: 1 mg/dL; female: 1 mg/dL
    • Age 10 to < 13 years: male: 1.2 mg/dL; female: 1.2 mg/dL
    • Age 13 to < 16 years: male: 1.5 mg/dL; female: 1.4 mg/dL
    • Age >= 16 years: male: 1.7 mg/dL; female: 1.4 mg/dL
  • Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL
  • Corrected QT (QTc) interval =< 480 milliseconds
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [V] 4.0) resulting from prior therapy must be =< grade 2
  • International normalized ratio (INR) =< 1.5
  • For subjects with CNS involvement (primary tumor or metastatic disease): Subjects must not have any active bleeding, or new intratumoral hemorrhage of more than punctate size on screening MRI or known bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment
  • Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
  • Patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; Note: Dexamethasone for CNS tumors or metastases, on a stable dose, is allowed
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received prior solid organ transplantation are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Open or close this module Contacts/Locations
Study Officials: Susan Chi
Principal Investigator
Children's Oncology Group
Locations: United States, Pennsylvania
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Susan N. Chi 617-632-4386 susan_chi@dfci.harvard.edu
Contact:Principal Investigator: Susan N. Chi
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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