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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening stage II, III, or IV mantle cell
lymphoma.

- Evaluate 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 antineoplaston A10 and antineoplaston AS2-1
intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues
in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months
for the third and fourth years, and then annually thereafter.

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 mantle cell lymphoma that is not curable
by surgery, radiotherapy, and/or chemotherapy

- Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in
head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)

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 20,000/mm^3

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

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 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 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:

- 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 corticosteroids (e.g., dexamethasone or prednisone)

- No concurrent dexamethasone, prednisone, or other corticosteroids

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:

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:

CDR0000066542

NCT ID:

NCT00003502

Start Date:

Completion Date:

Related Keywords:

  • Contiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Burzynski ClinicHouston, Texas  77055-6330