Antineoplaston Therapy in Treating Children With Visual Pathway Glioma

NCT00003477 | Completed Phase 2 Results

• 2 other identifiers: CDR0000066514BC-BT-23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

Conditions

Visual Pathway Glioma

Keywords

visual pathway glioma not amenable to standard therapy; visual pathway glioma not responding to standard therapy

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. Stable Disease (SD): \<50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.

  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

Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).

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

Antineoplaston therapy

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy. * Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry * Tumor must be at least 5 mm * No brain stem tumors PATIENT CHARACTERISTICS: Age: * 6 months to 17 years Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2000/mm3 * Platelet count greater than 50,000/mm3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal insufficiency * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No severe heart disease * No uncontrolled hypertension * No history of congestive heart failure * No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No serious active infections or fever * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas) * No concurrent antineoplastic agents Endocrine therapy: * Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No prior antineoplaston therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Publications (1)

• Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski. Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for BT-23. Cancer and Clinical Oncology 6(1): 25-35, 2017

  BACKGROUND

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Interventions

antineoplaston A10; antineoplaston AS 2-1

Results Point of Contact

• Title: S. R. Burzynski, MD, PhD
• Organization: Burzynski Research Institute, Inc.

srb@burzynskiclinic.com

713-335-5664

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1996
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 24, 2017
• Results First Posted: December 16, 2016

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)