Antineoplaston Therapy in Treating Patients With Brain Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00003457
• Other study ID #: CDR0000066489
• Secondary ID: BC-BT-9
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2009
• Start date: July 1996

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with brain tumors.

Description:

OBJECTIVES:

• Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors.

• Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Patients achieving partial response or stable disease continue treatment until disease progression.

Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.

PROJECTED ACCRUAL: Not specified

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists

• Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography

• Tumor must be at least 5 mm

• Ineligible for other BRI brain tumor protocols

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hemoglobin at least 9 g/dL

• WBC at least 2,000/mm^3

• Platelet count at least 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 history of 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

• No concurrent immunomodulating agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry)

Radiotherapy:

• At least 8 weeks since prior radiotherapy

Surgery:

• Must recover from prior surgery

Other:

• Prior cytodifferentiating agent allowed

• No prior antineoplaston therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• antineoplaston A10

• antineoplaston AS2-1

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate based on tumor measurements at 12 weeks			No
Secondary	Survival at 1, 2, and 5 years from the start of treatment			No