Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00003537
• Other study ID #: CDR0000066585
• Secondary ID: BC-BT-8
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2009
• Start date: April 1995

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 residual or recurrent anaplastic astrocytoma.

Description:

OBJECTIVES:

• Determine the objective response rate in patients with anaplastic astrocytoma treated with antineoplastons A10 and AS2-1 after subtotal resection.

• Assess tolerance to and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV 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 stable disease or partial response may continue treatment. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR.

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

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed anaplastic astrocytoma

• Tumor subtotally resected or biopsied

• Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography

• 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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Brain and Central Nervous System Tumors
• 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 assessed by tumor measurements at 12 weeks			No
Secondary	Survival at 1, 2, and 5 years from the start of treatment			No