Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

08:17 EDT 30th October 2014 | BioPortfolio

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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory high-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma after receiving chemotherapy.

Description

OBJECTIVES:

- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening recurrent or refractory high-grade non-Hodgkin's 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 antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily 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 at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years.

Patients are followed for survival.

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

antineoplaston A10, antineoplaston AS2-1

Location

Burzynski Clinic
Houston
Texas
United States
77055-6330

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

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