What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving HDAC inhibitors and PI3K inhibitors like CUDC-907, often have side effects such as fatigue, nausea, diarrhea, and cytopenias (reduced blood cell counts). Patients may also experience infections due to immunosuppression, liver enzyme abnormalities, and gastrointestinal symptoms. Skin reactions and metabolic disturbances, such as hyperglycemia, are also reported. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of lymphoma that target similar pathways to CUDC-907. For instance, HDAC inhibitors like vorinostat (Zolinza) and romidepsin (Istodax) have been approved for cutaneous T-cell lymphoma. Additionally, PI3K inhibitors such as idelalisib (Zydelig) and copanlisib (Aliqopa) have been approved for certain types of non-Hodgkin lymphoma. These drugs work by inhibiting key enzymes involved in cancer cell growth and survival, similar to the dual inhibition approach of CUDC-907.

What other types of research exist?

Promising novel alternatives to CUDC-907 for lymphoma patients include: 1) Venetoclax, a BCL-2 inhibitor, which has shown efficacy in combination with other agents for relapsed and refractory lymphomas. 2) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated significant responses in various types of lymphoma. 3) Bispecific antibodies like mosunetuzumab, targeting CD20 and CD3, which have shown promising results in clinical trials. 4) PD-1 inhibitors, such as pembrolizumab and nivolumab, which are being explored in combination with other therapies for enhanced efficacy.

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Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor

CUDC-907 for Pediatric Cancer

Phase 1

Waitlist Available

Led By David S Shulman, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial is testing a new drug called CUDC-907 to see if it can help children with certain cancers that haven't responded to other treatments. The drug works by blocking proteins that help cancer cells grow. The main goal is to find the safest dose for children and see if the drug has any benefits.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with relapsed or refractory solid tumors, CNS tumors, or lymphoma. They must have a performance status of at least 50%, measurable disease, normal organ function, be able to swallow medication without chewing, and not be pregnant or breastfeeding. Participants need stable neurological conditions and can't be on certain medications like corticosteroids (unless for specific diseases), NSAIDs, anticoagulants, or have uncontrolled illnesses.

What is being tested?

The study is testing CUDC-907's effectiveness in treating pediatric patients who haven't responded well to standard treatments for various types of cancer including neuroblastoma and brain tumors. It aims to find out if this new drug can help where other treatments haven't worked.

What are the potential side effects?

While the exact side effects are not listed here, similar drugs often cause reactions such as nausea, fatigue, blood count changes leading to increased infection risk; potential allergic reactions; and possibly effects on heart rhythm or liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Exposure (AUC) of CUDC-907 in Pediatrics

Peak plasma concentration of CUDC-907 in Pediatrics

Side effects data

From 2019 Phase 2 trial • 70 Patients • NCT02674750

72%

Diarrhea

54%

Hypokalemia

49%

Nausea

41%

Thrombocytopenia

40%

Hypomagnesia

35%

Fatigue

34%

Decreased appetite

28%

Vomiting

28%

Dehydration

26%

Anemia

26%

Dyspnea

21%

Constipation

21%

Arthralgia

21%

Neutropenia

19%

Pyrexia

19%

Pain in extremity

19%

Hyperuricemia

19%

Dizziness

18%

Abdominal Pain

18%

Hypocalcemia

16%

Back pain

16%

Acute Kidney Injury

13%

Cough

12%

Peripheral edema

10%

Diffuse Large B Cell lymphoma

Musculoskeletal pain

Upper Respiratory Infection

Oropharyngeal Pain

Headache

Asthensia

Dysgeusia

Atrial fibrillation

Pruritus

Dyspepsia

Chills

Insomnia

Sepsis

Lymphoma

Diarhhea

Disease Progression

COPD

Asthenia

Non-cardiac chest pain

Small Intestinal Obstruction

Citrobacter Batremia

Cytomegalovirus

Abdominal Pain Upper

hyperbilirubenemia

Enterococcal

Pneumonia

Febrile Neutropenia

Cholecystitis

Gullain-Barre Syndrome

Device occulsion

Pulmonary Embolism

Wound infection

Tracheal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

CUDC-907

Trial Design

1Treatment groups

Experimental Treatment

Group I: CUDC-907Experimental Treatment1 Intervention

* CUDC-907 orally administered * CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing * Dose level assigned at registration * Pre-dose pharmacokinetic blood sample will be collected * Dose escalation will follow a standard 3+3 design

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CUDC-907

2016

Completed Phase 2

~120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lymphoma treatments often target specific cellular pathways to inhibit cancer growth and survival. CUDC-907, a dual HDAC and PI3K inhibitor, works by blocking histone deacetylases (HDACs) and phosphoinositide 3-kinases (PI3Ks), which are crucial for cancer cell proliferation and survival. By inhibiting these pathways, CUDC-907 can induce cancer cell death and reduce tumor growth. Other common treatments include monoclonal antibodies like rituximab, which target specific proteins on cancer cells, and chemotherapy agents that kill rapidly dividing cells. Understanding these mechanisms is vital for patients as it helps them grasp how treatments can effectively target and manage their lymphoma.

Signal Pathways and Therapeutic Prospects of Diffuse Large B Cell Lymphoma.