Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer

NCT ID: NCT00003532

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-05
• Study Completion Date: 2002-10-18

Brief Summary

Current therapies for Stage III or IV Ovarian 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 III or IV Ovarian Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.

Detailed Description

Stage III or IV Ovarian 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 III or IV Ovarian 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 III or IV Ovarian 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.

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Keywords

Stage III ovarian epithelial cancer; Stage IV ovarian epithelial cancer; Stage III ovarian germ cell tumor; Stage IV ovarian germ cell tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal)

Intervention Type: DRUG

Patients with Stage III or IV Ovarian 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.

Interventions

Antineoplaston therapy (Atengenal + Astugenal)

Patients with Stage III or IV Ovarian 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.

Intervention Type: DRUG

Other Intervention Names

A10 (Atengenal); AS2-1 (Astugenal)

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III or IV epithelial or germ cell ovarian cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
• Measurable disease by CT scan or MRI

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:

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

Renal:

• Creatinine no greater than 2.5 mg/mL
• 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 other 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 for 4 weeks before, during, and for 4 weeks after study participation
• No active infection
• No concurrent serious systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulating agents

Chemotherapy:

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

Endocrine therapy:

• Concurrent corticosteroids allowed (e.g., dexamethasone or methylprednisone)

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed
• No prior antineoplaston therapy
• No other concurrent antineoplastic agents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Burzynski Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislaw R. Burzynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Burzynski Research Institute

Locations

Burzynski Clinic

Houston, Texas, United States

Countries

United States

Related Links

http://www.burzynskiresearch.com

Burzynski Research Institute

http://www.burzynskiclinic.com

Burzynski Clinic

Other Identifiers

BC-OV-2

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066579

Identifier Type: -

Identifier Source: org_study_id