Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

NCT ID: NCT00003537

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-04-30
• Study Completion Date: 2008-10-31

Brief Summary

RATIONALE: Current therapies for adults with anaplastic astrocytoma 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 anaplastic astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.

Detailed Description

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma 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 anaplastic astrocytoma.

OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma 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. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

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

Adult Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antineoplaston therapy

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.

Group Type: EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal)

Intervention Type: DRUG

Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Interventions

Antineoplaston therapy (Atengenal + Astugenal)

Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Intervention Type: DRUG

Other Intervention Names

A10 (Atengenal); AS2-1 (Astugenal)

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma
• Tumor subtotally resected or biopsied prior to therapy
• Evidence of residual tumor by MRI scan performed within two weeks prior to study entry
• No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC at least 1,500/mm^3
• Platelet count at least 50,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal
• No hepatic failure

Renal:

• Creatinine no greater than 2.5 mg/dL
• No renal failure

Cardiovascular:

• No prior congestive heart failure
• No coronary artery disease
• No myocardial infarction within the past year
• No angina requiring medication
• No uncontrolled hypertension

Pulmonary:

• No moderate to severe 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 other concurrent serious disease
• No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy
• No concurrent immunomodulating agents

Chemotherapy:

• No prior myelosuppressive chemotherapy

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

• No prior myelosuppressive radiotherapy
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• Recovered from any prior surgery

Other:

• No prior cytodifferentiating agents
• No prior antineoplaston therapy
• No other concurrent antineoplastic agents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burzynski Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislaw R. Burzynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Burzynski Research Institute

Locations

Burzynski Clinic

Houston, Texas, United States

Countries

United States

References

Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Newly-Diagnosed Anaplastic Astrocytoma Final Report (Protocol BT-08). Cancer and Clinical Oncology 4: 28-38, 2015. DOI: http://dx.doi.org/10.5539/cco.v4n1p28

Reference Type: BACKGROUND

Related Links

http://www.burzynskiresearch.com

Burzynski Research Institute

http://www.burzynskiclinic.com

Burzynski Clinic

Other Identifiers

BC-BT-8

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066585

Identifier Type: -

Identifier Source: org_study_id