Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer

Burzynski Research Institute

Status and phase: Terminated; Phase 2

Conditions: Metastatic Prostate Cancer

Treatments: Drug: Antineoplaston therapy (Atengenal + Astugenal)

Study type: Interventional

Funder types: Other

Identifiers

NCT00003533

CDR0000066580

BC-PR-4 (Other Identifier)

Details and patient eligibility

About

Current therapies for Metastatic 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 Metastatic Pancreatic Cancer.

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

Full description

Metastatic 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 Metastatic 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 Metastatic 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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically proven incurable, metastatic, hormone-refractory adenocarcinoma of the prostate that is unlikely to respond to existing therapy

  • Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
  • Stage D2

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hemoglobin at least 9 g/dL
• 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:

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

Cardiovascular:

• No known chronic heart failure
• 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 severe chronic obstructive pulmonary disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy (unless progression documented upon discontinuation of hormones)
• Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months before study entry

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agent allowed

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Antineoplaston therapy

Experimental 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.

Treatment:

Drug: Antineoplaston therapy (Atengenal + Astugenal)