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Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: October 24, 2008
Last verified: October 2008

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 is studying how well antineoplaston therapy works in treating patients with cancer of unknown primary origin.

Condition Intervention Phase
Carcinoma of Unknown Primary
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of Unknown Primary

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 1996
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:


  • Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of unknown primary.
  • 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 unacceptable 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 for 1 year and then every 3 months for 1 year.

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


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of unknown primary 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



  • 6 months and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months


  • WBC at least 2,000/mm^3
  • Platelet count at least 50,000/mm^3


  • No hepatic insufficiency
  • Bilirubin no greater than 2.5 mg/dL
  • SGOT and SGPT no greater than 5 times upper limit of normal


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


  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium


  • No severe lung disease, such as chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No active infection
  • No nonmalignant systemic disease
  • Not a high medical or psychiatric risk


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent immunomodulating agents


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

  • Concurrent corticosteroids allowed


  • At least 8 weeks since prior radiotherapy


  • Recovered from prior surgery


  • Prior cytodifferentiating agents allowed
  • No prior antineoplastons
  • No other concurrent antineoplastic agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003526

United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Responsible Party: Stanislaw R. Burzynski, Burzynski Clinic Identifier: NCT00003526     History of Changes
Other Study ID Numbers: CDR0000066570  BC-UP-2 
Study First Received: November 1, 1999
Last Updated: October 24, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of unknown primary
recurrent carcinoma of unknown primary

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on October 21, 2016