A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)

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.

Eligibility

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

Conditions3

Interventions1

Locations1 site

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