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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with recurrent or refractory Waldenstrom's macroglobulinemia.

- Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous
injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of toxicity or disease progression.
Patients achieving complete response (CR) continue treatment for an additional 8 months
after reaching CR.

Tumors are measured every 2 months the first year and every 3 months the second year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia
that is unlikely to respond to existing therapy, including surgery, radiotherapy, and
chemotherapy

- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

- Must have received and failed at least one standard first-line therapy (e.g.,
corticosteroid/alkylator combination)

- Biochemical evidence of Waldenstrom's macroglobulinemia

- Abnormal proteins in serum and urine

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count at least 50,000/mm3

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:

- No renal insufficiency

- 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 other cardiovascular conditions that contraindicate high dosages of
sodium

Pulmonary:

- No serious lung disease, such as chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study

- No active infection

- No non-malignant systemic disease

- Not a high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

- No concurrent immunomodulating agent

Chemotherapy:

- See Disease Characteristics

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

- No concurrent antineoplastic agents

Endocrine therapy:

- See Disease Characteristics

- Concurrent corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 8 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- No prior antineoplastons

- Prior cytodifferentiating agents allowed

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:

CDR0000066555

NCT ID:

NCT00003512

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Waldenstrom macroglobulinemia
  • Neoplasms
  • Lymphoma
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Burzynski ClinicHouston, Texas  77055-6330