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Antineoplastons A10 and AS2-1 in Stage IV Cervical or Vulvar Cancer
NCT00003525Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 1996
- Primary completion
- Jan 1998
- Countries
- 1
- Sponsor
- Burzynski Research Institute
- Modality
- Peptides, Small Molecules
- Conditions
- Cervical Cancer (CC)vulvar cancer
01
Overview
Phase 2, open-label, single-arm trial of antineoplaston A10 and antineoplaston AS2-1 in Cervical Cancer (CC) and vulvar cancer, sponsored by Burzynski Research Institute. Primary endpoint: Objective Response to Therapy up to 12 months. Started Jun 1996; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Antineoplaston therapy
Atengenal + Astugenal IV infusion
03
Who it enrols
Patients with histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva, measurable disease > 2cm, and adequate organ function.
04
Endpoints
Primary
Objective Response to Therapy
Secondary
Safety and Tolerance of Antineoplaston Therapy
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