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Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma


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

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with recurrent or progressing multiple myeloma after standard first line
therapy.

- 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 antineoplaston A10 and antineoplaston 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 and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.

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

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically and biochemically confirmed recurrent or progressing multiple myeloma
that is unlikely to respond to existing therapy, including surgery, radiotherapy, and
chemotherapy

- At least one standard first line therapy failure

- No localized plasmacytoma or plasmacytosis limited to the bone marrow

- Evidence of tumor by MRI or CT scan

- Presence of myeloma proteins in serum and urine, including Bence-Jones proteins

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

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

- No hepatic insufficiency

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal problems

- No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe 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 serious medical or psychiatric disorders

- No active infections

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulating agents

Chemotherapy:

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

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered (patients with multiple
tumors who have received radiotherapy to some, but not all, tumors may be admitted
earlier than 8 weeks)

Surgery:

- Must be recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by laboratory results 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:

CDR0000066554

NCT ID:

NCT00003511

Start Date:

April 1996

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Burzynski Clinic Houston, Texas  77055-6330