Antineoplaston Therapy in Treating Patients With Neurofibroma and Schwannoma

NCT02988726 | Terminated Phase 2

• 1 other identifier: BC-BT-19
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

CNS Tumor

Keywords

Neurofibroma; Schwannoma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Percentage of Participants who Survived

  6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Study Arms (1)

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.

Drug: Antineoplaston therapy (Atengenal + Astugenal)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

Adults with a recurrent/residual Neurofibroma or Schwannoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Also known as: A10 (Atengenal); AS2-1 (Astugenal)

Antineoplaston therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed incurable Neurofibroma or Schwannoma. Histological confirmation is waived for tumor location where biopsy cannot be safely performed.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neurofibroma; Neurilemmoma

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Peripheral Nervous System Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 9, 2016
• Study Start: March 1, 1999
• Primary Completion: August 1, 2001
• Study Completion: August 1, 2001
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)