Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of Unknown Primary
NCT00003526CI-TRIAL-00048880terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Cancer of Unknown Primary Origin.
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 |
|---|---|---|---|
| Unknown Primary Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antineoplaston therapy (Atengenal + Astugenal) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antineoplaston therapy
- description
- 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.
- interventionNames
- Drug: Antineoplaston therapy (Atengenal + Astugenal)
Primary outcomes (1)
- measure
- Number of Participants With Objective Response or Stable Disease
- timeFrame
- 5 months
- description
- Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of unknown primary that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy * Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan PATIENT CHARACTERISTICS: Age: * 6 months 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: * No hepatic insufficiency * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times upper limit of normal Renal: * No renal insufficiency * Creatinine no greater than 2.5 mg/dL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe 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 nonmalignant systemic disease * Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * At least 8 weeks since prior radiotherapy Surgery: * Recovered from prior surgery Other: * Prior cytodifferentiating agents allowed * No prior antineoplastons * No other concurrent antineoplastic agents
References
Publications (0)
Data not yet available
No reference posted for this study.