Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Uterine Cervical Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Diseases

Vulvar Cancer

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.

Antineoplaston therapy (Atengenal + Astugenal)

Stanislaw R. Burzynski, MD, PhD

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.

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.

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

Burzynski Research Institute

The patient will receive Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy.

Whole pelvis radiation therapy will be delivered according to institutional standard of care.

SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning.

Radiation Therapy

Loren Mell, MD

The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.

This is a Phase II, single-center, single-arm, study of Stereotactic Body Radiotherapy boost for stage IB-IVB cervical cancer.

The primary objective of the study is to test the hypothesis that stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

Study participants will be recruited within the UCSD Health System. For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study. The investigator will approach the subject and offer participation in the trial. If the patient chooses to participate, they will undergo pretreatment evaluations to determine if they are a good candidate to participate further in the study. Depending on when the patient last had these tests and procedures performed, some of them may not need to be repeated.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled subject will receive radiation therapy consisting of 30 to 35 treatments. The patient will first undergo Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks, followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy. Concurrent chemotherapy may be given with radiation therapy according to the discretion of the treating oncology team. No chemotherapy will be given during the SBRT phase of treatment. During radiation therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and evaluations for stress, anxiety, and pain.

Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer

To quantify treatment-related symptoms of post traumatic stress to determine if stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT.

To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30).

To measure health-related quality of life based on the cervical cancer module (CX24).

To quantify intrafraction cervical motion using cone beam computed tomography.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva	NCT00003525	Cervical Cancer... Vulvar Cancer, ...	Antineoplaston ...	18 Years - 99 Years	Burzynski Research Institute
Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva	NCT00003525	Cervical Cancer... Vulvar Cancer, ...	Antineoplaston ...	18 Years - 99 Years	Burzynski Research Institute
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for cervical cancer stage iv