Sulindac for Patients With AML

NCT01843179 | Withdrawn Phase 2 DMC

• 1 other identifier: 12-302
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved the use of sulindac for your type of cancer. Participants in this study must have undergone previous chemotherapy and achieved complete remission, which is the absence of disease activity in people with a chronic illness, in this case AML. Unfortunately, a significant number of patients with AML who achieve a complete remission with initial chemotherapy eventually experience a relapse, often within a few months. Previous research studies have demonstrated that a type of medication frequently used to treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX inhibitors are ibuprofen and naproxen. For this study, the investigators are using a COX inhibitor called sulindac, which has been FDA approved and used to treat pain and inflammation for many years, and has also been studied in suppressing certain tumors of the gastrointestinal system. The main goal of this study is to determine whether sulindac can help participants remain in a state of complete remission following the initial course of chemotherapy for AML, and two cycles of chemotherapy that is standard of care for your cancer, called consolidation chemotherapy. During the course of this study, the investigators will also attempt to learn more about how COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by studying the participants on this trial.

Conditions

Acute Myeloid Leukemia

Keywords

Newly diagnosed; Complete Remission

Outcome Measures

Primary Outcomes (1)

• Efficacy of sulindac in maintaining complete remission

  To define the efficacy of the COX inhibitor sulindac in maintaining complete remission in older patients with AML who achieve remission after induction chemotherapy

  2 years

Secondary Outcomes (3)

• Assess and grade toxicity of sulindac treatment

  2 years

• Assessment of survival

  2 years

• Correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes

  2 years

Study Arms (1)

Sulindac Treatment Arm

EXPERIMENTAL

Induction Chemotherapy followed by treatment with sulindac

Drug: Cytarabine; Drug: Sulindac

Interventions

Cytarabine DRUG

Up to two cycles. Administered via IV infusion on Days 1-5 of each 28 day cycle

Sulindac Treatment Arm

Sulindac DRUG

Taken orally twice per day at home for 12 months

Sulindac Treatment Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed newly diagnosed acute myelogenous leukemia in complete remission following induction chemotherapy

You may not qualify if:

• Plan for consolidative stem cell transplant in CR1 at the time of enrollment
• Previous history of coronary artery disease or heart failure
• Previous history of major allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs
• Previous history of gastric or duodenal ulceration
• Diagnosis of acute promyelocytic leukemia
• Diagnosis of acute bilineal/biphenotypic leukemia
• History of a different malignancy unless disease free for at least 5 years or diagnosed and treated for cervical cancer in situ, basal or squamous cell carcinoma of the skin
• Uncontrolled intercurrent illness that would limit compliance with study requirements
• Disseminated intravascular coagulation
• HIV positive on combination anti-retroviral therapy
• Known active hepatitis B or C
• History of coronary artery disease
• Current or history of congestive heart failure
• History of ventricular arrhythmia
• Patients with mental deficits or psychiatric conditions that preclude them form giving informed consent and following protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Pathologic Complete Response

Interventions

Cytarabine; Sulindac

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Amir Fathi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 30, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

US (1)