Clinical Trial Details
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NCT02909777 : Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma
PhasePhase 1
AgesMin: 1 Year Max: 21 Years
Inclusion Criteria:

- Age > 1 years and = 21 years at time of enrollment.

- Karnofsky performance status = 50% for patients =16 years of age and Lansky = 50% for
patients <16 years of age (see Appendix A)

- Diagnosis requirement

- For Parts A and B, participants must have evaluable or measurable disease (see Section

- For Part A, participants must have histologically confirmed solid tumors, CNS tumors,
or lymphoma based upon biopsy or surgery at initial diagnosis and/or
relapse/progression. The only exception to histologic confirmation is for pediatric
tumors that are routinely diagnosed exclusively by standard clinical imaging criteria:
diffuse intrinsic pontine glioma and optic pathway glioma.

- For Part B, participants must have one of the following diagnoses histologically

- Neuroblastoma with evidence of Mycn/Myc positivity based on any of the following:

- MYCN amplification (> 4 copy amplification) from COG reference laboratory or
other CLIA-certified laboratory; or

- Mycn protein expression > 1+ according to validated assay in Children's
Hospital Los Angeles (CHLA) Clinical Pathology Laboratory; or

- Myc expression > 1+ according to validated assay in CHLA Clinical Pathology

- One of the following mature B cell lymphoma diagnoses:

- Diffuse large B cell lymphoma

- Burkitt lymphoma

- Participants must have disease that is relapsed or refractory and for which standard
curative or palliative measures do not exist or are no longer effective.

- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer therapy except organ function as noted in Section 3.1.6). Patients must
meet the following minimum washout periods prior to enrollment:

- Myelosuppressive chemotherapy: At least 14 days after the last dose of
myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C).

- Radiotherapy:

- At least 14 days after local palliative XRT (small port);

- At least 90 days must have elapsed after prior TBI, craniospinal XRT or if >50%
radiation of pelvis;

- At least 42 must have elapsed if other substantial BM radiation;

- At least 42 days must have passed since last MIBG or other radionuclide therapy.

- Small molecule biologic therapy: At least 7 days following the last dose of a biologic
agent. For agents with known adverse events occurring beyond 7 days, this duration
must be extended beyond the time in which adverse events are known to occur. If
extended duration is required, this should be discussed and approved by the study

- Monoclonal antibody: At least 21 days after the last dose of anitbody

- Myeloid growth factors: At least 14 days following the last dose of long-acting growth
factor (e.g. Neulasta) or 7 days following short-acting growth factor.

- Stem Cell Infusion or Cellular Therapies: The patient must have no evidence of graft
versus host disease and at least 42 days must have elapsed after transplant, stem cell
infusion, or cellular therapy.

- Major Surgery: At least 3 weeks from prior major surgical procedure. Note: Biopsy and
central line placement/removal are not considered major.

- PI3K and HDAC inhibitors: The patient must not have received prior CUDC-907 therapy.
Prior treatment with individual PI3K or HDAC inhibitors is allowed. Patients must not
have received therapy with the combination of PI3K and HDAC inhibitors.

- Participants must have normal organ function as defined below.

- Bone Marrow Function:

- Absolute neutrophil count =1,000/uL

- Platelets =75,000/uL and transfusion independent, defined as not receiving a
platelet transfusion for at least 5 days prior to CBC documenting eligibility.

- Hepatic Function:

- Total bilirubin = 1.5 x upper limit of normal for age

- ALT (SGPT) = 135 U/L For the purpose of this study, the ULN for ALT is 45 U/L

- Serum albumin > 2 g/dL

- Renal Function:

--A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine
(mg/dL) Male Female

1. to < 2 years 0.6 0.6

2. to < 6 years 0.8 0.8

6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4

= 16 years 1.7 1.4 OR

--Creatinine clearance = 70 mL/min/1.73 m2 for participants with creatinine levels
above institutional normal.

- Adequate Cardiac Function: QTc < 480 msec

- Adequate GI Function: Diarrhea < grade 2 by CTCAE version 4

- Adequate Metabolic Function: Fasting glucose < grade 2 (< 160 mg/dL or < 8.9 mmol/L)
without the use of antihyperglycemic agents.

- Additional Agent-Specific Requirements

- Patients must be able to swallow either intact capsules or mini-tabs without chewing.

- In order to limit dose deviations due to rounding, patients must have a body surface
area of at least 0.5 m2

- For patients with CNS tumors (primary or metastatic), any baseline neurologic deficits
(including seizure) must be stable for at least one week prior to study enrollment.

- Ability to understand and/or the willingness of the patient (or parent or legally
authorized representative, if minor) to provide informed consent, using an
institutionally approved informed consent procedure.

Exclusion Criteria:

- Patients must not be receiving any of the following concomitant medications:

- Pharmacologic doses of systemic corticosteroids unless for CNS metastatic or primary
disease. For patients with CNS metastatic or primary tumors receiving corticosteroids,
they should be on a stable or decreasing dose over the 7 days prior to registration
and meet criteria.

- For all patients, receipt of systemic physiologic replacement steroids, topical and/or
inhaled corticosteroids is acceptable.

- Non-steroidal anti-inflammatory drugs, oral anticoagulants, and therapeutic heparins.

- Pregnant participants will not be entered on this study given that the effects of
CUDC-907 on the developing human fetus are unknown.

- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with CUDC-907, breastfeeding mothers are not

- Participants of child-bearing or child-fathering potential must agree to use adequate
contraception (hormonal birth control; intrauterine device; double barrier method; or
total abstinence) throughout their participation, including up until 30 days after
last dose of CUDC-907.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to CUDC-907.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements. Note that patients who have had prior allogeneic transplantation
are required to have CMV PCR testing performed during screening. A positive screen
would be evidence of an active infection and would render the patient ineligible.

- Patients with a known history of HIV, hepatitis B, and/or hepatitis C (testing not
required as part of screening).

- Patients with a known history of type 1 or type 2 diabetes mellitus.

- Patients with gastrointestinal disease or disorder that could interfere with
absorption of CUDC-907, such as bowel obstruction or inflammatory bowel disease.
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