Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma

NCT00003468 | Completed Phase 2 Results

• 2 other identifiers: CDR0000066504BC-BT-13
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Current therapies for children with low grade astrocytomas that 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 low grade astrocytomas that 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 (\> 6 months of age) with low grade astrocytomas that has not responded to standard therapy.

Conditions

Low Grade Astrocytomas

Keywords

childhood low-grade astrocytoma; recurrent childhood astrocytoma; persistent childhood astrocytoma

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

Children with a low grade astrocytoma that have 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 low grade astrocytoma. * Evidence of persistent or progressive tumor after standard therapy by MRI scan performed within 2 weeks prior to study entry * Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: * 6 months to 17 years Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count greater than 50,000/mm\^3 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 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 participation * 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 (6 weeks for nitrosoureas) and recovered * 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 entry) 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)

• Burzynski, SR, Janicki, TJ, Burzynski, G.S. A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas-Final Report (Protocol BT-13). Submitted to Journal of Cancer Therapy, 2016

  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: July 1, 1996
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: November 21, 2023
• Results First Posted: November 10, 2016

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)