Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Study Overview
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Brief Summary
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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 primary central nervous system lymphoma.

Detailed Description
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OBJECTIVES: Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system lymphoma. Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day 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 responding or stable disease may continue treatment. Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Official Title
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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: antineoplaston A10
* Drug: antineoplaston AS2-1
* Procedure: alternative product therapy
* Procedure: biological therapy
* Procedure: biologically based therapies
* Procedure: cancer prevention intervention
* Procedure: complementary and alternative therapy
* Procedure: differentiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists Measurable tumor by MRI or CT scan Tumor must be greater than 2 cm in largest diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2,000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal No hepatic insufficiency Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No cardiac insufficiency No hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 weeks after study participation No serious infection requiring antibiotics, antifungals, or antivirals PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulatory agents (e.g., interferon or interleukin-2) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agent Endocrine therapy: Concurrent corticosteroids allowed Must be on stable dose for at least 4 weeks prior to study entry Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No prior antineoplastons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antineoplaston A10|nan|
|Drug: antineoplaston AS2-1|nan|
|Procedure: alternative product therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: biologically based therapies|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: complementary and alternative therapy|nan|
|Procedure: differentiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |