Sulindac for Patients With AML

• Status: Withdrawn
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Cytarabine; Sulindac

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• Pregnant