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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00003532
Other study ID # CDR0000066579
Secondary ID BC-OV-2
Status Terminated
Phase Phase 2
First received November 1, 1999
Last updated December 11, 2017
Start date March 5, 1996
Est. completion date October 18, 2002

Study information

Verified date December 2017
Source Burzynski Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date October 18, 2002
Est. primary completion date October 18, 2002
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

Drug:
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.

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, 

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