Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer

• Sponsor: Burzynski Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00003531
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 111.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Pancreatic Cancer	Drug: Antineoplaston therapy (Atengenal + Astugenal)	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Pancreas
• Actual Study Start Date: Apr 10, 1996
• Actual Primary Completion Date: Jul 18, 2005
• Actual Study Completion Date: Jul 18, 2005

Arms and Interventions

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 immediately followed by infusion of AS2-1.; Other Names: A10 (Atengenal); AS2-1 (Astugenal)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Objective Response and Stable Disease [14 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic:

• No hepatic insufficiency

• Bilirubin no greater than 2.5 mg/dL

• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

• No renal insufficiency

• Creatinine no greater than 2.5 mg/dL

• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No uncontrolled hypertension

• No history of congestive heart failure

• No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease, such as chronic obstructive pulmonary disease

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

• No concurrent immunomodulating agents

Chemotherapy:

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

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed

• No prior antineoplastons

• No other concurrent antineoplastic agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burzynski Clinic	Houston	Texas	United States	77055-6330

Sponsors and Collaborators

• Burzynski Research Institute

Investigators

• Principal Investigator: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Burzynski Research Institute
• Burzynski Clinic

Publications

None provided.

• Responsible Party: Burzynski Research Institute
• ClinicalTrials.gov Identifier: NCT00003531
• Other Study ID Numbers: CDR0000066578; BC-PA-2
• First Posted: Jan 27, 2003
• Last Update Posted: Jan 7, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Burzynski Research Institute: Adenocarcinoma of the pancreas
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	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. 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 immediately followed by infusion of AS2-1.
Period Title: Overall Study
STARTED	15
COMPLETED	5
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	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. 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 immediately followed by infusion of AS2-1.
Overall Participants	15
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60.7
Sex: Female, Male (Count of Participants)
Female	5 33.3%
Male	10 66.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Objective Response and Stable Disease
Description	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.
Time Frame	14 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	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. 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 immediately followed by infusion of AS2-1.
Measure Participants	5
Stable Disease	1 6.7%
Progressive Disease	4 26.7%

Adverse Events

Time Frame	9 years, 3 months
Adverse Event Reporting Description	Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	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. 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 immediately followed by infusion of AS2-1.
All Cause Mortality
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	5/15 (33.3%)
Gastrointestinal disorders
Constipation	1/15 (6.7%)
Hemorrhage, GI	1/15 (6.7%)
Pain: Abdomen NOS	1/15 (6.7%)
Infections and infestations
Central Venous Catheter Infection	1/15 (6.7%)
Lung (pneumonia)	2/15 (13.3%)
Nervous system disorders
Confusion	1/15 (6.7%)
Somnolence/depressed level of consciousness	1/15 (6.7%)
Skin and subcutaneous tissue disorders
Edema/Fluid retention	1/15 (6.7%)
Other (Not Including Serious) Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	15/15 (100%)
Blood and lymphatic system disorders
Hemoglobin	3/15 (20%)
Lymphopenia	3/15 (20%)
Ear and labyrinth disorders
tinnitus	1/15 (6.7%)
Gastrointestinal disorders
Constipation	1/15 (6.7%)
Diarrhea	4/15 (26.7%)
Gastrointestinal-Other	1/15 (6.7%)
Nausea	6/15 (40%)
Taste alteration (dysgeusia)	1/15 (6.7%)
Vomiting	2/15 (13.3%)
Hemorrhage, GI	1/15 (6.7%)
Pain: Abdomen NOS	1/15 (6.7%)
General disorders
Allergic reaction/hypersensitivity (including drug fever)	2/15 (13.3%)
Fatigue (asthenia, lethargy, malaise)	6/15 (40%)
Fever	1/15 (6.7%)
Rigors/chills	2/15 (13.3%)
Edema/Fluid retention	8/15 (53.3%)
Pain: Head/headache	2/15 (13.3%)
Infections and infestations
Central Venous Catheter Infection	1/15 (6.7%)
Infection (documented clinically): Blood	1/15 (6.7%)
Lung (pneumonia)	3/15 (20%)
Infection (documented clinically): Mucosa	1/15 (6.7%)
Infection (documented clinically): Soft tissue NOS	1/15 (6.7%)
Opportunistic infection	1/15 (6.7%)
Investigations
PT	1/15 (6.7%)
PTT	2/15 (13.3%)
Albumin, serum-low (hypoalbuminemia)	1/15 (6.7%)
Hyperbilirubinemia	1/15 (6.7%)
Hyperglycemia	6/15 (40%)
Hypernatremia	8/15 (53.3%)
Hypocalcemia	2/15 (13.3%)
Hypoglycemia	1/15 (6.7%)
Hypokalemia	12/15 (80%)
Hypomagnesemia	1/15 (6.7%)
Hyponatremia	1/15 (6.7%)
SGOT	4/15 (26.7%)
Musculoskeletal and connective tissue disorders
Pain: Joint	1/15 (6.7%)
Nervous system disorders
Confusion	6/15 (40%)
Dizziness	2/15 (13.3%)
Psychosis (hallucinations/delusions)	1/15 (6.7%)
Somnolence/depressed level of consciousness	5/15 (33.3%)
Speech impairment	1/15 (6.7%)
Renal and urinary disorders
Urinary frequency/urgency	1/15 (6.7%)
Skin and subcutaneous tissue disorders
Pruritus/itching	1/15 (6.7%)
Vascular disorders
Thrombosis/thrombus/embolism	1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.