Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas
Study Details
Study Description
Brief Summary
Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. These acetogenins have been shown to be selective and toxic against various types of cancer cells in-vitro and in-vivo experimental animal models. In spite of this evidence of anti tumor activity of Graviola, no prospective clinical studies have been carried out to determine if it also has clinical activity.The Investigator have observed two patients at Auxilio Mutuo Cancer Center who experienced significant tumor shrinkage while taking a tea made of Graviola leaves. Neither of these patients were taking any other treatment for their cancer. The investigator propose to conduct a study using guanabana leaves extract in patients with Gastroesophageal junction(GEJ) adenocarcinoma, as well as in Gastric adenocarcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Low Grade Lymphomas and Colorectal adenocarcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Patients with relapsed/refractory gastric adenocarcinoma, adenocarcinoma of gastroesophageal junction, hepatocellular carcinoma, colorectal adenocarcinoma will be eligible. Colorectal adenocarcinomas will be eligible after failing second line therapy while the remainder will be eligible after first line therapy depending on the judgment of the treating oncologist. Any patient who refuse to receive chemotherapy will also be eligible even if they have not received chemotherapy. Patients with low grade lymphomas including chronic lymphocytic leukemias whose favorable blood counts and lack of symptoms make the candidates for "watch and wait" approach as well as any patient with low grade lymphoma who because of age or co-morbidity might not be eligible for chemotherapy or who refuse chemotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Overall Statistical design We will treat 9 patients of each tumor type with a tea made of Graviola Leaves. If no responses are observed then the trial will be closed for that particular histological type. Should a response occur, then the trial will continue to the second stage for that cell type until 24 patients are accrued. If 3 or more responses are observed out of 24 cases, then the result will be considered promising. |
Dietary Supplement: Tea Made of Graviola Leaves
Graviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day.
The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment.
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Outcome Measures
Primary Outcome Measures
- RECIST criteria [Through study completion, an average of 3 years.]
RECIST criteria will be used to measure response in solid tumors.
- Cheson criteria [Through study completion, an average of 3 years.]
Cheson criteria will be used for lymphomas.
- Blood Counts [Through study completion, an average of 3 years.]
Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Understand and voluntarily sign an informed consent form.
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Age > 18 years at the time of signing the informed consent form.
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Willing and able to adhere to the study visit schedule and other protocol requirements.
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Must have measurable or evaluable disease.
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All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
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Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at study entry.
Exclusion Criteria:
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Patients actively taking guanabana or guanabana tea daily or who have used it at some point after their diagnosis of cancer.
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Patients with Parkinson's disease.
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Serum Total Bilirubin ≥ 3.0 mg/dL
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Serum Creatinine level ≥ 3.0 mg/dL
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Central Nervous System (CNS) involvement.
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Known human immunodeficiency virus (HIV) infection; Known active hepatitis B or hepatitis C infection.
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Females who are pregnant (positive urine test) or breast-feeding females.
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Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Auxilio Mutuo Cancer Center | San Juan | Puerto Rico | 00918 |
Sponsors and Collaborators
- Auxilio Mutuo Cancer Center
Investigators
- Principal Investigator: Fernado Cabanillas, MD, Hospital Español Auxilio Mutuo Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
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- Sun S, Liu J, Zhou N, Zhu W, Dou QP, Zhou K. Isolation of three new annonaceous acetogenins from Graviola fruit (Annona muricata) and their anti-proliferation on human prostate cancer cell PC-3. Bioorg Med Chem Lett. 2016 Sep 1;26(17):4382-5. doi: 10.1016/j.bmcl.2015.06.038. Epub 2015 Jun 25.
- Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.
- Torres MP, Rachagani S, Purohit V, Pandey P, Joshi S, Moore ED, Johansson SL, Singh PK, Ganti AK, Batra SK. Graviola: a novel promising natural-derived drug that inhibits tumorigenicity and metastasis of pancreatic cancer cells in vitro and in vivo through altering cell metabolism. Cancer Lett. 2012 Oct 1;323(1):29-40. doi: 10.1016/j.canlet.2012.03.031. Epub 2012 Apr 1.
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- CCAM 18-01