Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
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
NCT00003517CI-TRIAL-00011301withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alternative product therapy | Procedure | — | UNRESOLVED |
| antiandrogen therapy | Procedure | — | UNRESOLVED |
| antineoplaston A10 | Drug | — | UNRESOLVED |
| antineoplaston AS2-1 | Drug | — | UNRESOLVED |
| bicalutamide | Drug | Bicalutamide | ALIAS |
| biologically based therapies | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| cancer prevention intervention | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.