Adenocarcinoma of the ProstatePhase 2NCT00003517
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
A Phase 2 study testing antineoplaston A10, antineoplaston AS2-1 and bicalutamide in people with Adenocarcinoma of the Prostate and Stage III Prostate Cancer, run by Burzynski Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Prostate, Stage III Prostate Cancer, Stage IV Prostate Cancer
- What is being tested?
- antineoplaston A10, antineoplaston AS2-1 and bicalutamide
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- antineoplaston A10, antineoplaston AS2-1, bicalutamide, flutamide, leuprolide acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antineoplaston A10Drug
antineoplaston AS2-1Drug
bicalutamideDrug
flutamideDrug
leuprolide acetateDrug
alternative product therapyProcedure or surgery
antiandrogen therapyProcedure or surgery
biological therapyProcedure or surgery
biologically based therapiesProcedure or surgery
cancer prevention interventionProcedure or surgery
complementary and alternative therapyProcedure or surgery
differentiation therapyProcedure or surgery
endocrine therapyProcedure or surgery
hormone therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burzynski Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Stanislaw R. Burzynski, MD, PhD, Study chair, Burzynski Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003517
- Sponsor's protocol ID
- BC-PR-6
- Other IDs
- CDR0000066560
- Status last verified
- Dec 2006
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00003517
- Acronym / sponsor ID
- BC-PR-6
- Conditions
- Adenocarcinoma of the Prostate, Stage III Prostate Cancer, Stage IV Prostate Cancer, Recurrent Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Burzynski Research InstituteUniversity, hospital or other
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antineoplaston A10 | Drug | – |
| antineoplaston AS2-1 | Drug | – |
| bicalutamide | Drug | – |
| flutamide | Drug | – |
| leuprolide acetate | Drug | – |
| alternative product therapy | Procedure or surgery | – |
| antiandrogen therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| biologically based therapies | Procedure or surgery | – |
| cancer prevention intervention | Procedure or surgery | – |
| complementary and alternative therapy | Procedure or surgery | – |
| differentiation therapy | Procedure or surgery | – |
| endocrine therapy | Procedure or surgery | – |
| hormone therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislaw R. Burzynski, MD, PhD study chair
Burzynski Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing antineoplaston A10, antineoplaston AS2-1 and bicalutamide in people with Adenocarcinoma of the Prostate and Stage III Prostate Cancer, run by Burzynski Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.