Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate
antineoplaston A10
+ antineoplaston AS2-1
+ bicalutamide
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude thérapeutique
Résumé
OBJECTIVES: Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor response. Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy. Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically proven localized, regional, or metastatic adenocarcinoma of the prostate Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy Measurable tumors or tumor markers Bone metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT no greater than 2 times normal Renal: No chronic renal failure BUN less than 60 mg/dL Creatinine no greater than 2.5 mg/dL OR Creatinine clearance greater than 60 mL/min Blood ammonia normal Cardiovascular: No severe heart disease Pulmonary: No severe lung disease Other: Fertile patients must use effective contraception during and for 4 weeks after study participation No serious active infections or fever No other prior or concurrent second malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: At least 4 weeks since prior investigational clinical trial No other concurrent treatment for metastatic prostate cancer
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site