Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Current therapies for Stage III or Stage IV Prostate 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 III or Stage IV Prostate Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antineoplaston therapy (Atengenal + Astugenal) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antineoplastons
- description
- Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Antineoplaston therapy (Atengenal + Astugenal)
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage III or IV adenocarcinoma of the prostate not potentially curable by surgery or radiotherapy * Measurable tumors or tumor markers * No response to antiandrogen withdrawal PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT no greater than 2 times normal * No hepatic failure Renal: * 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 * No chronic renal failure 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 infection or fever * No other concurrent serious disease * No other prior or concurrent malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior hormonal therapy and recovered * Prior corticosteroids for at least 2 months allowed, but must be on stable or decreasing dose during study participation Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery and recovered Other: * At least 4 weeks since prior experimental clinical trial * No other concurrent therapy for metastatic disease
References
Publications (0)
Data not yet available