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Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors

Sponsor
Burzynski Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00003515
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
22
Actual Duration (Days)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antineoplaston therapy (Atengenal + Astugenal)
 Phase 2

Detailed Description

OVERVIEW: This is a single arm, open-label study in which patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors 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 Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors, 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 Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.

  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System
Actual Study Start Date :
Dec 12, 1996
Actual Primary Completion Date :
Jan 3, 1997
Actual Study Completion Date :
Jan 3, 1997

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antineoplaston therapy

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.

Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other Names:
  • A10 (Atengenal); AS2-1 (Astugenal)

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      6 Months to 99 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      DISEASE CHARACTERISTICS:

      • Histologically confirmed incurable primitive neuroectodermal tumors outside the central nervous system that are unlikely to respond to existing therapy, meeting 1 of the following criteria:

      • Metastatic disease

      • Progressive, recurrent, or refractory disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy

      • Measurable disease by MRI or CT scan

      • Tumor must be at least 2 cm

      PATIENT CHARACTERISTICS:
      Age:
      • 6 months 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:

      • 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 participation

      • No active infection

      • No nonmalignant systemic disease

      • Not a high medical or psychiatric risk

      PRIOR CONCURRENT THERAPY:
      Biologic therapy:

      • At least 4 weeks since prior immunotherapy

      • No concurrent immunomodulating agents

      Chemotherapy:

      • See Disease Characteristics

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

      Endocrine therapy:
      • Concurrent corticosteroids allowed
      Radiotherapy:

      • See Disease Characteristics

      • At least 8 weeks since prior radiotherapy

      Surgery:

      • See Disease Characteristics

      • Recovered from prior surgery

      Other:

      • Prior cytodifferentiating agents allowed

      • No prior antineoplastons

      • No other concurrent antineoplastic agents

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Burzynski Clinic Houston Texas United States 77055-6330

      Sponsors and Collaborators

      • Burzynski Research Institute

      Investigators

      • Principal Investigator: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Burzynski Research Institute
      ClinicalTrials.gov Identifier:
      NCT00003515
      Other Study ID Numbers:
      • CDR0000066558
      • BC-PN-02
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Sep 29, 2017
      Last Verified:
      Sep 1, 2017
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Burzynski Research Institute
      Metastatic Primitive Neuroectodermal Tumor
      Recurrent Primitive Neuroectodermal Tumor
      Refractory Primitive Neuroectodermal Tumor
      Additional relevant MeSH terms:
      Neuroectodermal Tumors
      Neuroectodermal Tumors, Primitive

      Study Results

      No Results Posted as of Sep 29, 2017