Trials / Withdrawn
WithdrawnNCT00003517
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Burzynski Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor response. * Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy. Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Conditions
- Adenocarcinoma of the Prostate
- Stage III Prostate Cancer
- Stage IV Prostate Cancer
- Recurrent Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | antineoplaston A10 | |
| DRUG | antineoplaston AS2-1 | |
| DRUG | bicalutamide | |
| DRUG | flutamide | |
| DRUG | leuprolide acetate | |
| PROCEDURE | alternative product therapy | |
| PROCEDURE | antiandrogen therapy | |
| PROCEDURE | biological therapy | |
| PROCEDURE | biologically based therapies | |
| PROCEDURE | cancer prevention intervention | |
| PROCEDURE | complementary and alternative therapy | |
| PROCEDURE | differentiation therapy | |
| PROCEDURE | endocrine therapy | |
| PROCEDURE | hormone therapy |
Timeline
- First posted
- 2003-01-27
- Last updated
- 2013-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003517. Inclusion in this directory is not an endorsement.