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Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas

Primary Purpose

Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Hepatocellular Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Puerto Rico

Study Type

Interventional

Intervention

Tea Made of Graviola Leaves

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age > 18 years at the time of signing the informed consent form.
Willing and able to adhere to the study visit schedule and other protocol requirements.
Must have measurable or evaluable disease.
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at study entry.

Exclusion Criteria:

Patients actively taking guanabana or guanabana tea daily or who have used it at some point after their diagnosis of cancer.
Patients with Parkinson's disease.
Serum Total Bilirubin ≥ 3.0 mg/dL
Serum Creatinine level ≥ 3.0 mg/dL
Central Nervous System (CNS) involvement.
Known human immunodeficiency virus (HIV) infection; Known active hepatitis B or hepatitis C infection.
Females who are pregnant (positive urine test) or breast-feeding females.
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.

Sites / Locations

Auxilio Mutuo Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overall Statistical design

Arm Description

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.

Outcomes

Primary Outcome Measures

RECIST criteria

RECIST criteria will be used to measure response in solid tumors.

Cheson criteria

Cheson criteria will be used for lymphomas.

Blood Counts

Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.

Secondary Outcome Measures

Full Information

NCT ID

NCT04773769

First Posted

December 4, 2018

Last Updated

February 24, 2021

Sponsor

Auxilio Mutuo Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04773769

Brief Title

Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas

Official Title

Pilot Phase 2 Study of Graviola (Guanabana) Leaves for The Treatment of Patients With Relapsed or Refractory Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphomas and Colorectal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Auxilio Mutuo Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphoma, Colorectal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Overall Statistical design

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Tea Made of Graviola Leaves

Intervention Description

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.

Primary Outcome Measure Information:

Title

RECIST criteria

Description

RECIST criteria will be used to measure response in solid tumors.

Time Frame

Through study completion, an average of 3 years.

Title

Cheson criteria

Description

Cheson criteria will be used for lymphomas.

Time Frame

Through study completion, an average of 3 years.

Title

Blood Counts

Description

Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.

Time Frame

Through study completion, an average of 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Understand and voluntarily sign an informed consent form. Age > 18 years at the time of signing the informed consent form. Willing and able to adhere to the study visit schedule and other protocol requirements. Must have measurable or evaluable disease. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study. Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at study entry. Exclusion Criteria: Patients actively taking guanabana or guanabana tea daily or who have used it at some point after their diagnosis of cancer. Patients with Parkinson's disease. Serum Total Bilirubin ≥ 3.0 mg/dL Serum Creatinine level ≥ 3.0 mg/dL Central Nervous System (CNS) involvement. Known human immunodeficiency virus (HIV) infection; Known active hepatitis B or hepatitis C infection. Females who are pregnant (positive urine test) or breast-feeding females. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando Cabanillas, MD

Phone

787-758-2000

Ext

3503

cabanillasmd@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernado Cabanillas, MD

Organizational Affiliation

Hospital Español Auxilio Mutuo Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Auxilio Mutuo Cancer Center

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Idalia Liboy, MD

Phone

787-758-2000

Ext

3569

iliboy@auxiliomutuo.com

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

First Name & Middle Initial & Last Name & Degree

Mirelis Acosta-Rivera, MD

First Name & Middle Initial & Last Name & Degree

Margarita Bruno, MD

First Name & Middle Initial & Last Name & Degree

Luis Cotto, MD

First Name & Middle Initial & Last Name & Degree

Joel López Figueroa, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Learn more about this trial

Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas

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