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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary


OBJECTIVES:

- Study the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable stage III or IV ovarian cancer.

- Describe response to, tolerance to, and side effects of this regimen in this patient
population.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times daily until the maximum tolerated dose level is reached.

Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after achieving CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066579

NCT ID:

NCT00003532

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • Ovarian Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330