A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
Roger Strair
Summary
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.
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 know…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- BiologicalSoursop 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.
Location
- MDA at Cooper University Health CareCamden, New Jersey