Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

Malignant Mesothelioma Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003508
• Other study ID #: CDR0000066551
• Secondary ID: BC-MA-2
• Status: Terminated
• Phase: Phase 2
• Start date: March 8, 1996
• Est. completion date: April 26, 2005

Study information

• Verified date: January 2021
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.

Description:

Advanced Mesothelioma 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 advanced Mesothelioma, 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 advanced Mesothelioma.

• To determine objective response, tumor size is measured utilizing physical examination and radiologic studies, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 26, 2005
• Est. primary completion date: April 26, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists

• Evidence of disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 1 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:

• Bilirubin no greater than 2.5 mg/dL

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

• Hepatic function adequate

Renal:

• Creatinine no greater than 2.5 mg/dL

• No renal insufficiency

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

Cardiovascular:

• No uncontrolled hypertension

• No history of congestive heart failure

• No cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 4 weeks after study participation

• Not at high medical or psychiatric risk

• No nonmalignant systemic disease

• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulatory agents

Chemotherapy:

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

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed

• No prior antineoplastons

• No other concurrent antineoplastic agents

Related Conditions & MeSH terms

• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Burzynski SR, Lewy RI, Axler M, Janicki TJ.Treatment of malignant mesothelioma (MM) with sodium phenylbutyrate.Presented at the 15th International Congress on Anti-Cancer Treatment; February 9-12, 2004, Paris, France.

Preliminary findings on the use of targeted therapy in combination with sodium phenylbutyrate in advanced malignant mesothelioma: A strategy for improved survival. Journal of Cancer Therapy. 2014; 5:1127-1144.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable	Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), < 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.	109 months