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Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia

Primary Purpose

Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Germinoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
gamma-secretase/Notch signalling pathway inhibitor RO4929097
diagnostic laboratory biomarker analysis
pharmacological study
dexamethasone
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Atypical Teratoid/Rhabdoid Tumor

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed malignancy (at diagnosis or relapse)

    • Biopsy not required for intrinsic brain stem tumors or optic pathway gliomas
  • No B-cell precursor acute lymphoblastic lymphoma (ALL) or acute myeloid leukemia
  • No T-cell leukemia with CNS3 disease
  • Measurable or evaluable disease
  • Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Neurologic deficits in patients with CNS tumors must have been relatively stable for 1 week
  • No active CNS leukemia
  • Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age)

    • 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 PS
  • Patients with solid tumors without bone marrow involvement must meet the following criteria:

    • Peripheral ANC ≥ 1,000/mm^3
    • Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
  • Patients with known bone marrow metastatic disease must meet the above criteria and must not be known to be refractory to red cell or platelet transfusion
  • Patients with leukemia must meet the following criteria:

    • Platelet count ≥ 20,000/mm^3 (may receive platelet transfusions)
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
    • Must not be known to be refractory to RBC or platelet transfusions
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age/gender as follows:

    • ≤ 0.6 mg/dL (patients 1 to < 2 years)
    • ≤ 0.8 mg/dL (patients 2 to < 6 years)
    • ≤ 1 mg/dL (patients 6 to < 10 years)
    • ≤ 1.2 mg/dL (patients 10 to < 13 years)
    • ≤ 1.4 mg/dL (female patients ≥ 13 years)
    • ≤ 1.5 mg/dL (male patients 13 to < 16 years)
    • ≤ 1.7 mg/dL (male patients ≥ 16 years)
  • Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN) for age
  • ALT ≤ 110 U/L (for the purpose of this study, the ULN for ALT is 45 U/L)
  • Serum albumin ≥ 2 g/dL
  • No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia defined as < lower limit of normal despite adequate electrolyte supplementation
  • Baseline QTc < 450 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception (i.e., one highly effective method and one additional effective method) for ≥ 4 weeks before, during, and for ≥ 12 months after completion of study treatment
  • Female patients may not donate ova during or after study treatment
  • Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator
  • Able to swallow tablets and capsules
  • No known malabsorption syndrome or other condition that would interfere with intestinal absorption
  • No known serological positivity for hepatitis A, B, or C, no known history of liver disease, and no other forms of hepatitis or cirrhosis
  • No known HIV positivity
  • No uncontrolled infection
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or dexamethasone
  • Patients may not donate blood during or for ≥ 12 months after completion of study treatment
  • No hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia that is uncontrolled despite adequate electrolyte supplementation
  • No prior gamma-secretase inhibitor RO4929097
  • Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors, CNS tumors, or lymphomas)
  • Patients with T-cell leukemia must meet the following criteria:

    • Patients who relapsed on standard ALL maintenance chemotherapy must not have received maintenance chemotherapy within the past 3 days
    • Patients who relapsed when they were not receiving standard ALL maintenance therapy are eligible provided it has been ≥ 14 days since the completion of cytotoxic chemotherapy with the exception of hydroxyurea
    • Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours before the start of study treatment
  • At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 3 months since prior stem cell transplantation or rescue without TBI and no evidence of active graft-vs-host disease
  • At least 7 days since the completion of therapy with a biologic agent

    • For agents 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)
  • At least 7 days or 3 half-lives, whichever is longer, since prior treatment with a monoclonal antibody
  • More than 7 days since prior growth factors that support platelet or white cell number or function
  • At least 7 days since prior corticosteroids
  • No other concurrent investigational drugs
  • No other concurrent anticancer agents including chemotherapy (except for hydroxyurea), radiotherapy, immunotherapy, or biologic therapy

    • Patients with T-ALL who benefit from treatment with gamma-secretase inhibitor RO4929097 in combination with dexamethasone may receive intrathecal methotrexate
  • No concurrent warfarin sodium (Coumadin®)
  • No concurrent medications that are strong inducers and/or inhibitors of CYP3A4
  • No concurrent medications or food that may interfere with the metabolism or gamma-secretase inhibitor RO4929097, including ketoconazole and fresh-squeezed grapefruit juice

Sites / Locations

  • Lucile Packard Children's Hospital Stanford University
  • Stanford University Hospitals and Clinics
  • Lurie Children's Hospital-Chicago
  • Indiana University Medical Center
  • Dana-Farber Cancer Institute
  • Washington University School of Medicine
  • Columbia University Medical Center
  • Nationwide Children's Hospital
  • St. Jude Children's Research Hospital
  • Baylor College of Medicine
  • Seattle Children's Hospital
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

GROUP A: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, 15-17, and 22-24. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent oral dexamethasone twice daily on the days of gamma-secretase inhibitor RO4929097 administration. Once the MTD or recommended phase II dose of RO4929097 plus dexamethasone in children with solid tumors, including CNS tumors, or lymphoma has been identified, this dose is used for patients with relapsed-refractory T-ALL (phase 2 portion of the study) to evaluate RO4929097 in combination with dexamethasone using one of the studied schedules.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of RO4929097 determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
MTD of RO4929097 administered with dexamethasone determined according to DLTs graded using CTCAE v4.0

Secondary Outcome Measures

Antitumor activity of RO4929097 with or without dexamethasone assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Full Information

First Posted
March 16, 2010
Last Updated
November 4, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01088763
Brief Title
Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia
Official Title
A PHASE 1/2 STUDY OF RO4929097, AN ORAL SMALL MOLECULE INHIBITOR OF GAMMA-SECRETASE, IN CHILDREN WITH RELAPSED/REFRACTORY SOLID OR CNS TUMORS, LYMPHOMA, OR T-CELL LEUKEMIA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase I/II clinical trial is studying the side effects and best dose of gamma-secretase inhibitor RO4929097 and to see how well it works in treating young patients with relapsed or refractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitor RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum-tolerated dose (MTD) and recommend a phase II dose of gamma-secretase inhibitor RO4929097 administered orally to children with relapsed or refractory solid tumors or lymphoma on two schedules: once daily orally on a 3-day on/4-day off weekly schedule (schedule A) or once daily for 5 consecutive days weekly schedule (schedule B). II. To define and describe the toxicities of this drug administered on these schedules to children with relapsed or refractory solid tumors, lymphoma, or T-cell leukemia. III. To estimate the MTD and recommended phase II dose of gamma-secretase inhibitor RO4929097 administered with dexamethasone. IV. To define and describe the toxicities of gamma-secretase inhibitor RO4929097 administered with dexamethasone. V. To characterize the pharmacokinetics of gamma-secretase inhibitor RO4929097 in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of gamma-secretase inhibitor RO4929097 in children with solid or CNS tumors and lymphoma within the confines of a phase I study. II. To obtain initial efficacy data on the antitumor activity of gamma-secretase inhibitor RO4929097 when combined with dexamethasone in children with relapsed-refractory T-cell leukemia (T-acute lymphoblastic leukemia [ALL]). III. To study the effect of gamma-secretase inhibitor RO4929097 on Hes1 (hairy/enhancer of split) and other components of the Notch signaling pathway in peripheral blood mononuclear cells and/or T-ALL blasts. (exploratory) IV. To examine archival tumor samples for expression of JAGGED1, JAGGED2, cleaved NOTCH1, and HES1, and HES5 by IHC and for amplification of NOTCH1 or NOTCH2 using FISH analysis. (exploratory) V. To preliminarily assess changes following treatment with gamma-secretase inhibitor RO4929097 using FDG PET imaging. (exploratory) OUTLINE: This is a multicenter, phase I, dose-escalation study of gamma-secretase inhibitor RO4929097 followed by a phase II study. Patients are enrolled sequentially to group A or B. GROUP A: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, 15-17, and 22-24. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent oral dexamethasone twice daily on the days of gamma-secretase inhibitor RO4929097 administration. Once the MTD or recommended phase II dose of RO4929097 plus dexamethasone in children with solid tumors, including CNS tumors, or lymphoma has been identified, this dose is used for patients with relapsed-refractory T-ALL (phase 2 portion of the study) to evaluate RO4929097 in combination with dexamethasone using one of the studied schedules. Blood, plasma, bone marrow, and tumor tissue samples may be collected at baseline and periodically during the first course for correlative lab and tumor studies, including pharmacokinetics. After completion of study treatment, patients are followed up for up to 30 days. *NOTE: This trial was intended to be Phase I/II, but the trial never continued to the Phase II portion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma, Childhood Central Nervous System Yolk Sac Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Ependymoblastoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood Infratentorial Ependymoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Gonadotroph Adenoma, Pituitary Basophilic Adenoma, Pituitary Chromophobe Adenoma, Pituitary Eosinophilic Adenoma, Prolactin Secreting Adenoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Central Nervous System Embryonal Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Spinal Cord Neoplasm, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Pituitary Tumor, Recurrent/Refractory Childhood Hodgkin Lymphoma, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, TSH Secreting Adenoma, Unspecified Childhood Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
GROUP A: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, 15-17, and 22-24. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent oral dexamethasone twice daily on the days of gamma-secretase inhibitor RO4929097 administration. Once the MTD or recommended phase II dose of RO4929097 plus dexamethasone in children with solid tumors, including CNS tumors, or lymphoma has been identified, this dose is used for patients with relapsed-refractory T-ALL (phase 2 portion of the study) to evaluate RO4929097 in combination with dexamethasone using one of the studied schedules.
Intervention Type
Drug
Intervention Name(s)
gamma-secretase/Notch signalling pathway inhibitor RO4929097
Other Intervention Name(s)
R4733, RO4929097
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Aeroseb-Dex, Decaderm, Decadron, DM, DXM
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of RO4929097 determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Time Frame
28 days
Title
MTD of RO4929097 administered with dexamethasone determined according to DLTs graded using CTCAE v4.0
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Antitumor activity of RO4929097 with or without dexamethasone assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy (at diagnosis or relapse) Biopsy not required for intrinsic brain stem tumors or optic pathway gliomas No B-cell precursor acute lymphoblastic lymphoma (ALL) or acute myeloid leukemia No T-cell leukemia with CNS3 disease Measurable or evaluable disease Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Neurologic deficits in patients with CNS tumors must have been relatively stable for 1 week No active CNS leukemia Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age) 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 PS Patients with solid tumors without bone marrow involvement must meet the following criteria: Peripheral ANC ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within the past 7 days) Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) Patients with known bone marrow metastatic disease must meet the above criteria and must not be known to be refractory to red cell or platelet transfusion Patients with leukemia must meet the following criteria: Platelet count ≥ 20,000/mm^3 (may receive platelet transfusions) Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) Must not be known to be refractory to RBC or platelet transfusions Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age/gender as follows: ≤ 0.6 mg/dL (patients 1 to < 2 years) ≤ 0.8 mg/dL (patients 2 to < 6 years) ≤ 1 mg/dL (patients 6 to < 10 years) ≤ 1.2 mg/dL (patients 10 to < 13 years) ≤ 1.4 mg/dL (female patients ≥ 13 years) ≤ 1.5 mg/dL (male patients 13 to < 16 years) ≤ 1.7 mg/dL (male patients ≥ 16 years) Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN) for age ALT ≤ 110 U/L (for the purpose of this study, the ULN for ALT is 45 U/L) Serum albumin ≥ 2 g/dL No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia defined as < lower limit of normal despite adequate electrolyte supplementation Baseline QTc < 450 msec Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception (i.e., one highly effective method and one additional effective method) for ≥ 4 weeks before, during, and for ≥ 12 months after completion of study treatment Female patients may not donate ova during or after study treatment Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator Able to swallow tablets and capsules No known malabsorption syndrome or other condition that would interfere with intestinal absorption No known serological positivity for hepatitis A, B, or C, no known history of liver disease, and no other forms of hepatitis or cirrhosis No known HIV positivity No uncontrolled infection No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or dexamethasone Patients may not donate blood during or for ≥ 12 months after completion of study treatment No hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia that is uncontrolled despite adequate electrolyte supplementation No prior gamma-secretase inhibitor RO4929097 Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors, CNS tumors, or lymphomas) Patients with T-cell leukemia must meet the following criteria: Patients who relapsed on standard ALL maintenance chemotherapy must not have received maintenance chemotherapy within the past 3 days Patients who relapsed when they were not receiving standard ALL maintenance therapy are eligible provided it has been ≥ 14 days since the completion of cytotoxic chemotherapy with the exception of hydroxyurea Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours before the start of study treatment At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis At least 6 weeks since other prior substantial bone marrow radiotherapy At least 2 weeks since prior local palliative radiotherapy (small port) At least 3 months since prior stem cell transplantation or rescue without TBI and no evidence of active graft-vs-host disease At least 7 days since the completion of therapy with a biologic agent For agents 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) At least 7 days or 3 half-lives, whichever is longer, since prior treatment with a monoclonal antibody More than 7 days since prior growth factors that support platelet or white cell number or function At least 7 days since prior corticosteroids No other concurrent investigational drugs No other concurrent anticancer agents including chemotherapy (except for hydroxyurea), radiotherapy, immunotherapy, or biologic therapy Patients with T-ALL who benefit from treatment with gamma-secretase inhibitor RO4929097 in combination with dexamethasone may receive intrathecal methotrexate No concurrent warfarin sodium (Coumadin®) No concurrent medications that are strong inducers and/or inhibitors of CYP3A4 No concurrent medications or food that may interfere with the metabolism or gamma-secretase inhibitor RO4929097, including ketoconazole and fresh-squeezed grapefruit juice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najat Daw
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia

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