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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone
marrow transplantation.

- Describe the 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 8 weeks 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven non-Hodgkin's disease that has failed both prior high-dose
chemotherapy and bone marrow transplantation

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 20,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

Renal:

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- 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 4 weeks after study
participation

- No serious active infections

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

Endocrine therapy:

- At least 4 weeks since prior corticosteroids

- No concurrent corticosteroids

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No prior antineoplaston therapy

- No other concurrent antineoplastic agents

- No concurrent antibiotics, antifungals, or antivirals

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements taken at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066537

NCT ID:

NCT00003498

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Burzynski ClinicHouston, Texas  77055-6330