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Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

B

Burzynski Research Institute

Status and phase

Terminated
Phase 2

Conditions

Stage IV Breast Cancer

Treatments

Drug: Antineoplaston therapy (Atengenal + Astugenal)

Study type

Interventional

Funder types

Other

Identifiers

NCT00003454
CDR0000066486
BC-BR-12 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.

Full description

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Stage IV breast cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV breast cancer.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Enrollment

19 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists

    • Must have failed prior standard therapy
  • Measurable disease by MRI or CT scan

  • Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal Status:

  • Not specified

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 nor greater than 2.5 mg/dL
  • SGOT/SGPT no greater than 5 times upper limit of normal
  • No hepatic failure

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No chronic heart failure
  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of 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 participation
  • No serious medical or psychiatric disorders
  • No active infections
  • No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy
  • Recovery from prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy
  • Recovery from prior chemotherapy
  • No concurrent antineoplastic agents

Endocrine therapy:

  • At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
  • Concurrent corticosteroids allowed
  • Recovery from prior hormonal therapy

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:

  • Recovered from any prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Antineoplaston therapy
Experimental group
Description:
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Treatment:
Drug: Antineoplaston therapy (Atengenal + Astugenal)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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