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Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus


OBJECTIVES:

- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable
adenocarcinoma of the esophagus.

- Describe 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
by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) continue treatment for at
least 8 months beyond CR. Patients achieving a partial response or stable disease continue
treatment until disease progression.

Tumors are measured every 2 months for 1 year and then every 3 months for the second year.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the esophagus that is unlikely to respond
to existing therapy and for which no curative therapy exists

- Meets 1 of the following criteria:

- Metastatic disease

- Not curable with surgery or radiotherapy

- Measurable disease by MRI or CT scan

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 failure

- 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/ml

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No chronic or congestive heart failure

- No uncontrolled hypertension

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

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

Other:

- Not pregnant or nursing

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

- No medical illness, psychiatric illness, or non-malignant systemic disease that would
preclude study treatment

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

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

Endocrine therapy:

- Concurrent steroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (except in patients with multiple tumors
who have received radiotherapy to some of their tumors) and recovered

Surgery:

- Recovered from prior surgery

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agents allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements taken at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

Unspecified

Study ID:

CDR0000066525

NCT ID:

NCT00003487

Start Date:

May 1996

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330