AML (Acute Myeloid Leukemia), Multiple Myeloma Refractory
Conditions
Keywords
relapsed/refractory
Brief 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.
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.
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.
Sponsors
Roger Strair
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dependent Variables or Outcome Measures | From enrollment until end of treatment- 21 days | Reduction in AML cell percentage in blood or bone marrow e.g. (a \>50% reduction in circulating leukemia cells) for the AML cohort. A 50 percent reduction in monoclonal protein or serum free light chains in the multiple myeloma cohort. Tea-associated toxicity will be graded by CTCAE v6 standards. |
Countries
United States
Contacts
CONTACTJohn Riehman-Murphy, RN
CONTACTRoseann Freitag
PRINCIPAL_INVESTIGATORRoger Strair, MD
Cooper University Health Care
Outcome results
None listed