Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
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ClinicalTrials.gov Identifier: NCT00003525 |
Recruitment Status
:
Terminated
(slow accrual)
First Posted
: January 27, 2003
Last Update Posted
: September 29, 2017
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Current therapies for Stage IV Cancer of the Cervix and/or Vulva 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 IV Cancer of the Cervix and/or Vulva.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Cancer of the Cervix and/or Vulva.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer Stage IV Vulvar Cancer, Stage IV | Drug: Antineoplaston therapy (Atengenal + Astugenal) | Phase 2 |
Stage IV Cancer of the Cervix and/or Vulva patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Stage IV Cancer of the Cervix and/or Vulva, 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 IV Cancer of the Cervix and/or Vulva.
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Uterine Cervix and/or Vulva |
Actual Study Start Date : | June 3, 1996 |
Actual Primary Completion Date : | January 22, 1998 |
Actual Study Completion Date : | January 22, 1998 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Cancer of the Cervix and/or Vulva 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. Other Name: A10 (Atengenal); AS2-1 (Astugenal)
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva that is unlikely to respond to existing therapy
- Measurable disease by MRI or CT scan
- Tumor must be at least 2 cm
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:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- No renal insufficiency
- 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 chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- 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
- No concurrent immunomodulatory agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
-
At least 1 month since prior tamoxifen if no progression
- May enter study immediately if evidence of progression
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003525
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Principal Investigator: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Responsible Party: | Burzynski Research Institute |
ClinicalTrials.gov Identifier: | NCT00003525 History of Changes |
Other Study ID Numbers: |
CDR0000066569 BC-UC-02 ( Other Identifier: Burzynski Research Institute ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 29, 2017 |
Last Verified: | September 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Burzynski Research Institute:
recurrent cervical cancer recurrent vulvar cancer |
Additional relevant MeSH terms:
Uterine Cervical Neoplasms Vulvar Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Vulvar Diseases |