Antineoplaston Therapy In Treating Patients With Stage IV Pancreatic Cancer

Study Overview

Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer

Current therapies for Stage IV Pancreatic Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Pancreatic Cancer.

Stage IV Pancreatic Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Stage IV Pancreatic Cancer

DRUG: Antineoplaston therapy (Atengenal + Astugenal)

CDR0000066578
BC-PA-2 (OTHER Identifier) (OTHER: Burzynski Research Institute)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted 2020-11-15	Last Update Submitted that met QC Criteria 2020-12-16
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria 2020-12-14	Last Update Posted (ACTUAL) 2021-01-07
First Posted (ACTUAL) 2003-01-27	Results First Posted 2020-12-17	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Antineoplaston therapy Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	DRUG: Antineoplaston therapy (Atengenal + Astugenal) Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Antineoplaston therapy

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

DRUG: Antineoplaston therapy (Atengenal + Astugenal)

Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Objective Response and Stable Disease	An objective response can be complete or partial. A complete response is complete disappearance of all tumor(s) by physical examination and radiographic studies for a minimum of 4 weeks. A partial response is > 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, lasting for a minimum of four months. Stable disease is < 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of 12 months.	14 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed stage IV adenocarcinoma of the pancreas that is unlikely to respond to existing therapy
Measurable disease by MRI or CT scan
Tumor must be at least 2 cm

18 and over

Karnofsky 60-100%

At least 2 months

WBC at least 2,000/mm^3
Platelet count at least 50,000/mm^3

No hepatic insufficiency
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal

No renal insufficiency
Creatinine no greater than 2.5 mg/dL
No history of renal conditions that contraindicate high dosages of sodium

No uncontrolled hypertension
No history of congestive heart failure
No history of other cardiovascular conditions that contraindicate high dosages of sodium

No serious lung disease, such as chronic obstructive pulmonary disease

Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No active infection
No nonmalignant systemic disease
Not a high medical or psychiatric risk

At least 4 weeks since prior immunotherapy
No concurrent immunomodulating agents

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Concurrent corticosteroids allowed

At least 8 weeks since prior radiotherapy

Recovered from prior surgery

Prior cytodifferentiating agents allowed
No prior antineoplastons
No other concurrent antineoplastic agents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Learn

Resources

Patients

Caregivers

Clinical Trial Record