Primitive Neuroectodermal TumorPhase 2NCT00003515
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
A Phase 2 study testing Antineoplaston therapy (Atengenal + Astugenal) in people with Primitive Neuroectodermal Tumor, run by Burzynski Research Institute at 1 site in United States.
Trial summary
Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors. Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Primitive Neuroectodermal Tumor
- What is being tested?
- Antineoplaston therapy (Atengenal + Astugenal)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 1996to 3 Jan 1997
- 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 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed incurable primitive neuroectodermal tumors outside the central nervous system that are unlikely to respond to existing therapy, meeting 1 of the following criteria:
- Metastatic disease
- Progressive, recurrent, or refractory disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy
- Measurable disease by MRI or CT scan
- Tumor must be at least 2 cm
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 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 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:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System
Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
Read the detailed description
OVERVIEW: This is a single arm, open-label study in which patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors, as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
- Conditions
- Primitive Neuroectodermal Tumor
- Being tested
- Antineoplaston therapy (Atengenal + Astugenal)
- Keywords
- Metastatic Primitive Neuroectodermal Tumor, Recurrent Primitive Neuroectodermal Tumor, Refractory Primitive Neuroectodermal Tumor
- Medical subject headings
- Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antineoplaston therapy (Atengenal + Astugenal)Drug
Also called A10 (Atengenal); AS2-1 (Astugenal)
Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
| Study group | Role | What they receive |
|---|---|---|
| Antineoplaston therapy | Experimental | 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. Receives: Drug: Antineoplaston therapy (Atengenal + Astugenal) |
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)
- Study start12 Dec 1996
- Primary completion3 Jan 1997
- Study completion3 Jan 1997
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primitive Neuroectodermal TumorStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burzynski Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislaw R. Burzynski, MD, PhD, Principal investigator, Burzynski Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003515
- Sponsor's protocol ID
- CDR0000066558
- Other IDs
- BC-PN-02
- Status last verified
- Sep 2017
- First submitted
- 1 Nov 1999
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System
- ClinicalTrials.gov ID
- NCT00003515
- Acronym / sponsor ID
- CDR0000066558
- Conditions
- Primitive Neuroectodermal Tumor
- Keywords
- Metastatic Primitive Neuroectodermal Tumor, Recurrent Primitive Neuroectodermal Tumor, Refractory Primitive Neuroectodermal Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Burzynski Research InstituteUniversity, hospital or other
- Study start
- 12 Dec 1996 (actual)
- Primary completion
- 3 Jan 1997 (actual)
- Study completion
- 3 Jan 1997 (actual)
- 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.
Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
Detailed description
OVERVIEW: This is a single arm, open-label study in which patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors, as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antineoplaston therapy | Experimental | Drug: Antineoplaston therapy (Atengenal + Astugenal)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. |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 therapy (Atengenal + Astugenal)Also: A10 (Atengenal); AS2-1 (Astugenal)Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1. | Drug | Antineoplaston therapy |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Burzynski Research InstituteLink provided by the sponsor.
- Burzynski ClinicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 principal investigator
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 therapy (Atengenal + Astugenal) in people with Primitive Neuroectodermal Tumor, 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: stopped early, as of the sponsor's last update on 29 Sep 2017. 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 stopped early (reason given: slow accrual). Results are not available in the source record.
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 29 Sep 2017.