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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

Unspecified

Study ID:

CDR0000066489

NCT ID:

NCT00003457

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • ACTH-producing pituitary tumor
  • TSH producing pituitary tumor
  • adult brain stem glioma
  • adult craniopharyngioma
  • adult medulloblastoma
  • adult meningioma
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult central nervous system germ cell tumor
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult ependymoblastoma
  • adult pineocytoma
  • adult pineoblastoma
  • adult meningeal hemangiopericytoma
  • adult choroid plexus tumor
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pineal gland astrocytoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330