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Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade


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

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Trial Information

Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage II, III, or IV high-grade non-Hodgkin's lymphoma that has
not responded to, or has relapsed after a standard primary chemotherapy regimen plus
at least 1 standard second-line salvage chemotherapy regimen NOTE: A new
classification scheme for adult non-Hodgkin's lymphoma has been adoptedby PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC greater than 2000/mm^3

- Platelet count greater than 50,000/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 uncontrolled hypertension

- No history of congestive heart failure

- No history of 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 active infection requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent antineoplastic agent

Endocrine therapy:

- At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids

- No concurrent corticosteroid

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No prior antineoplaston therapy

- No concurrent antibiotics, antifungals, or antivirals

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066541

NCT ID:

NCT00003501

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Burzynski ClinicHouston, Texas  77055-6330