Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

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 Kidney Cancer 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 Kidney Cancer 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 Kidney Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Kidney Cancer.

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV Kidney Cancer 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.

OBJECTIVE S:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV Kidney Cancer, 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 Kidney Cancer.
* 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 Kidney Cancer

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Kidney

Burzynski Research Institute

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Lung Neoplasms

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urinary Bladder Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Patients receive ASQ brochure and complete questionnaires over 30 minutes at baseline, over 10 minutes pre-clinic visit, and over 30 minutes post-clinic visit.

Behavioral Intervention

Susan Eggly, PhD

This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.

Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.

Ask Questions (ASQ):Implementation of a Communication Intervention

Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting

6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)

generally (before) and in a specific physician (after): (5 items20 Likert scale)

Distress thermometer (one item, Likert scale (no distress - extreme distress)

Barbara Ann Karmanos Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer	NCT00003520	Stage IV Kidney...	Antineoplaston ...	18 Years - 99 Years	Burzynski Research Institute
Ask Questions (ASQ):Implementation of a Communication Intervention	NCT05025748	Stage II Breast... Stage III Breas... Stage IV Breast... Stage II Colore... Stage III Color... Stage IV Colore... Stage II Lung C... Stage III Lung ... Stage IV Lung C... Stage II Prosta... Stage III Prost... Stage IV Prosta... Stage II Ovaria... Stage III Ovari... Stage IV Ovaria... Stage II Cervic... Stage III Cervi... Stage II Bladde... Stage III Bladd... Stage IV Bladde... Stage II Kidney... Stage III Kidne... Stage IV Kidney...	Behavioral Inte...	18 Years -	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for stage iv kidney cancer