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Purpose

Purpose/Specific Aims The study will determine if there is a reduction in malignant cell burden when patients with relapsed and/or refractory acute myeloid leukemia (AML) or multiple myeloma (MM) consume tea made from the dried leaves of Annona muricata (Soursop). The study goal is to determine the safety and anti-neoplastic efficacy of Annona muricata tea when taken in escalating frequency over a period of 21 days by patients with relapsed/refractory AML or MM for whom there are no standard therapeutic options.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with relapsed or refractory AML or MM not on any anti-neoplastic therapy who have exhausted all therapies and have no available therapy. - For AML: Quantifiable leukemia cells in blood (patients without circulating AML blasts may participate if they agree to baseline and post-treatment bone marrow testing) - For MM: Quantifiable M component (SPEP) or serum free light chain abnormality (ratio greater than 10) - ECOG PS 0,1, or 2 - ALT, AST less than 3 times ULN - Bilirubin (total) < 2.5 mg/dL - Renal function - estimated GFR > 40 ml/min - No uncontrolled/active infections - Negative pregnancy test if of childbearing potential - No chronic neurologic disorders (peripheral neuropathy > grade 2; Parkinson's disease; Alzheimer's disease; other neurologic diseases will be discussed with the PI)

Exclusion Criteria

  • Inability to understand the study procedures - Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML)
  • Biological: Soursop tea
    The study is designed to test soursop tea therapy for 21 days, seven at each of 3 dose levels (1, 2 and 3 eight-ounce cups of soursop tea/d with each tea bag containing 1.5g of Shavuot leaves). Some patients may be on study for longer periods due to delays for toxicity observation. Only one delay will be allowed per patient. The patients will be assessed for leukemic or myeloma burden at the end of therapy. All patients will be monitored until resolution of tea-associated toxicities. All patients continuing soursop tea after the 21 days of treatment will continue to be followed for response and toxicity. If a specific intervention-associated CTCAE grade 2 or greater irreversible toxicity occurs in more than one person, the study will be stopped.
Experimental
10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM)
  • Biological: Soursop tea
    The study is designed to test soursop tea therapy for 21 days, seven at each of 3 dose levels (1, 2 and 3 eight-ounce cups of soursop tea/d with each tea bag containing 1.5g of Shavuot leaves). Some patients may be on study for longer periods due to delays for toxicity observation. Only one delay will be allowed per patient. The patients will be assessed for leukemic or myeloma burden at the end of therapy. All patients will be monitored until resolution of tea-associated toxicities. All patients continuing soursop tea after the 21 days of treatment will continue to be followed for response and toxicity. If a specific intervention-associated CTCAE grade 2 or greater irreversible toxicity occurs in more than one person, the study will be stopped.

Recruiting Locations

MDA at Cooper University Health Care
Camden, New Jersey 18103

More Details

Status
Recruiting
Sponsor
Roger Strair

Study Contact

John Riehman-Murphy, RN
215-756-2772
riehmanmurphy-john1@cooperhealth.edu

Detailed Description

Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM) are aggressive blood cancers. The median age of patients diagnosed with AML is between 65 and 70 years old and, despite recent advances in the management, most studies demonstrate less than 25% 5-year survival of patients over age 60. Likewise, although there have been extraordinary breakthroughs in the care of patients with MM, most patients with MM currently ultimately die of their disease. Annona muricata is a plant that is native to Central and South America and found also in parts of the Caribbean, Europe, Asia and Africa. It is known by various names throughout the world (soursop, gravioloa, guanabana, paw paw, nangka balanda, and others). Seeds, fruit and leaves from the plant have all been used to treat a variety of diseases and ailments. The leaves are acuminate with a dark green upper surface and extracts include a variety of pharmacologically active classes of molecules (acetogenins, alkaloids, flavonoids) and a variety of their secondary products. This pilot study is designed to determine if there is any signal of anti-neoplastic activity when patients with refractory/relapsed AML or MM with no standard therapeutic options available consume soursop tea.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.