- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003525
Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Uterine Cervix and/or Vulva
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77055-6330
- Burzynski Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066569
- BC-UC-02 (Other Identifier: Burzynski Research Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer Stage IV
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Uterine Corpus Sarcoma | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Recurrent Cervical Carcinoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Stage I Uterine... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedLymphedema | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Stage III Vulvar Cancer | Stage IVB Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vulvar Cancer | Stage I Vulvar Cancer | Stage IA Cervical Cancer | Stage IB Cervical... and other conditionsUnited States
-
The University of The West IndiesUnknownStage IV Breast Cancer | Stage IV Prostate Cancer | Stage IV Colon Cancer | Stage IV Cancer of the CervixJamaica
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Stage IV Endometrial Carcinoma | Stage I Ovarian Epithelial Cancer | Stage II Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Stage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage... and other conditionsUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)CompletedStage IV Lung Cancer | Stage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Malignant Female Reproductive System Neoplasm | Stage III... and other conditionsUnited States
-
University of PittsburghCompletedBreast Cancer Stage IV | Cervical Cancer Stage IIIB | Cervical Cancer Stage IVA | Cervical Cancer Stage IVB | Ovarian Cancer Stage IV | Ovarian Cancer Stage III | Endometrial Cancer Stage III | Endometrial Cancer Stage IV | Vulvar Cancer, Stage IV | Vulvar Cancer, Stage III | Vaginal Cancer Stage III | Vaginal... and other conditionsUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)WithdrawnCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3 | Stage III Vulvar Cancer | Recurrent Cervical Cancer | Recurrent Vaginal Cancer | Recurrent Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vaginal Cancer | Stage 0 Vulvar... and other conditions
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
Clinical Trials on Antineoplaston therapy (Atengenal + Astugenal)
-
Burzynski Research InstituteCompletedLow Grade AstrocytomasUnited States
-
Burzynski Research InstituteTerminatedMalignant MesotheliomaUnited States
-
Burzynski Research InstituteTerminatedStage IV Non-small Cell Lung CancerUnited States
-
Burzynski Research InstituteTerminatedStage IV Ovarian Cancer | Stage III Ovarian CancerUnited States
-
Burzynski Research InstituteTerminatedSmall Intestine CancerUnited States
-
Burzynski Research InstituteTerminatedNeuroblastomaUnited States
-
Burzynski Research InstituteCompletedMalignant Brain TumorsUnited States
-
Burzynski Research InstituteTerminated
-
Burzynski Research InstituteTerminatedUnknown Primary CarcinomaUnited States
-
Burzynski Research InstituteTerminatedMetastatic Prostate CancerUnited States