CNS TumorPhase 2NCT02988726
Antineoplaston Therapy in Treating Patients With Neurofibroma and Schwannoma
A Phase 2 study testing Antineoplaston therapy (Atengenal + Astugenal) in people with CNS Tumor, run by Burzynski Research Institute at 1 site in United States.
Trial summary
RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with a recurrent/residual Neurofibroma or Schwannoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CNS 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
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Aug 2001
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed incurable Neurofibroma or Schwannoma. Histological confirmation is waived for tumor location where biopsy cannot be safely performed.
- There will be no exclusion based on multifocality, or leptomeningeal or systemic metastases.
- The tumor must be at least 5 mm in size.
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI performed no more than 14 days before the beginning of therapy.
- Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agents are eligible.
- Patients who did not receive standard therapy are eligible.
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- Patients may be male or female. If female, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If male, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.
- Patient must sign the Informed Consent Document indicting an awareness of the experimental nature of this study. In the event the patient has impairment of higher intellectual function, for example, aphasia, the the patient's legal next of kin or legal guardian must sign the Informed Consent Document indicating an awareness of the experimental nature of the study.
- Patient must fully recover from the operative procedure and have life expectancy of two months or more. The patient's performance status should be consistent with outpatient therapy, i.e., 60% - 100% Karnofsky. The use of corticosteroids is permitted to reduce symptoms attributed to cerebral edema. It is recommended that the smallest dose be used compatible with the preservation of optimal neurological function.
- Minimal hematological parameters include a hemoglobin of at least 9 g/dL, a white blood count of at least 1500, and a platelet count of at least 50,000.
- Patients with no evidence of hepatic or renal insufficiency; a total serum bilirubin and creatinine not higher than 2.5 mg/dL; and a SGOT and SGPT not higher than 5 times the upper limit of normal.
- Patients must recover from the adverse effect of previous therapy. At least eight weeks must have lapsed since the last dose of radiation therapy and at least four weeks must have lapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.
Who cannot join
- Failure to meet all inclusion criteria.
- Patient either pregnant or breast feeding an infant.
- Patient is a high medical or psychiatric risk, having non-malignant systemic disease, which would, in the opinion of the investigator, make therapy with an investigational agent unwise.
- Patient is incompetent to give informed consent to treatment. However, the patient may be admitted if a legally appointed guardian gives consent.
- Presence of an active infection.
- Patients with known chronic heart failure and serious lung disease, such as severe COPD.
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- Patients with hypertension are excluded unless the hypertension is adequately controlled.
- Patients who have had prior Antineoplaston treatment should be excluded from this protocol.
- Patients who do not have adequate hepatic function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Antineoplastons A19 and AS2-1 in Patients With Neurofibroma and Schwannoma
RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with a recurrent/residual Neurofibroma or Schwannoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.
Read the detailed description
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/residual Neurofibroma or Schwannoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in adults with a recurrent/residual Neurofibroma or Schwannoma, 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 adults with a recurrent/residual Neurofibroma or Schwannoma.
- 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.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
- Conditions
- CNS Tumor
- Being tested
- Antineoplaston therapy (Atengenal + Astugenal)
- Keywords
- Neurofibroma, Schwannoma
- Medical subject headings
- Central Nervous System Neoplasms, Neurofibroma, Neurilemmoma
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)
Adults with a recurrent/residual Neurofibroma or Schwannoma will receive Antineoplaston therapy (Atengenal + Astugenal).
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Objective Response
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks.
Measured: 12 months
Secondary outcomes (1)
Percentage of Participants who Survived
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Measured: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startMar 1999
- Primary completionAug 2001
- Study completionAug 2001
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 CNS 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
- 3 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
- NCT02988726
- Sponsor's protocol ID
- BC-BT-19
- Status last verified
- Jul 2017
- First submitted
- 22 Nov 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Antineoplastons A19 and AS2-1 in Patients With Neurofibroma and Schwannoma
- ClinicalTrials.gov ID
- NCT02988726
- Acronym / sponsor ID
- BC-BT-19
- Conditions
- CNS Tumor
- Keywords
- Neurofibroma, Schwannoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Burzynski Research InstituteUniversity, hospital or other
- Study start
- Mar 1999
- Primary completion
- Aug 2001 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 9 Dec 2016 (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: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with a recurrent/residual Neurofibroma or Schwannoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.
Detailed description
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/residual Neurofibroma or Schwannoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in adults with a recurrent/residual Neurofibroma or Schwannoma, 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 adults with a recurrent/residual Neurofibroma or Schwannoma.
- 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.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
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
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed incurable Neurofibroma or Schwannoma. Histological confirmation is waived for tumor location where biopsy cannot be safely performed.
- There will be no exclusion based on multifocality, or leptomeningeal or systemic metastases.
- The tumor must be at least 5 mm in size.
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI performed no more than 14 days before the beginning of therapy.
- Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agents are eligible.
Key exclusion criteria (9 listed)
- Failure to meet all inclusion criteria.
- Patient either pregnant or breast feeding an infant.
- Patient is a high medical or psychiatric risk, having non-malignant systemic disease, which would, in the opinion of the investigator, make therapy with an investigational agent unwise.
- Patient is incompetent to give informed consent to treatment. However, the patient may be admitted if a legally appointed guardian gives consent.
- Presence of an active infection.
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)Adults with a recurrent/residual Neurofibroma or Schwannoma will receive Antineoplaston therapy (Atengenal + Astugenal). | Drug | Antineoplaston therapy |
Primary outcome
Number of Participants with Objective Response
Time frame: 12 months
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks.
1 secondary outcome
Percentage of Participants who Survived
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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 26 Jul 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 CNS 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?
The sponsor lists 12 inclusion and 9 exclusion criteria. 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 26 Jul 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.
What does the primary outcome measure?
Number of Participants with Objective Response (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 26 Jul 2017.