Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Colon Cancer
Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
NCT00003486CI-TRIAL-00011296withdrawnPhase 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 colon cancer.
Conditions
Conditions (3)
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 Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alternative product therapy | Procedure | — | UNRESOLVED |
| antineoplaston A10 | Drug | — | UNRESOLVED |
| antineoplaston AS2-1 | Drug | — | UNRESOLVED |
| biologically based therapies | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| cancer prevention intervention | Procedure | — | UNRESOLVED |
| complementary and alternative therapy | Procedure | — | UNRESOLVED |
| differentiation therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists * Measurable disease by MRI or CT scan * Metastatic or unresectable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal failure Cardiovascular: * No chronic heart failure * No uncontrolled hypertension Pulmonary: * No serious lung disease, such as chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No active infection * No serious malabsorption syndromes * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) Surgery: * No prior extensive stomach or intestinal surgery Other: * Prior cytodifferentiating agent allowed * No prior antineoplaston therapy * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.