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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003532
First Posted: January 27, 2003
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
January 27, 2003
July 24, 2008
August 1998
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Complete list of historical versions of study NCT00003532 on ClinicalTrials.gov Archive Site
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Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have stage III or stage IV ovarian cancer

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.

Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003532
CDR0000066579
BC-OV-2
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Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP