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Phase 2 N=40 Treatment

Antineoplaston Therapy in Treating Patients With Brain Tumors

Refractory Brain Tumors

Enrolled (actual)
40
Serious AEs
67.5%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants With Objective Response — 4; 5; 12; 10 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Antineoplaston therapy (Atengenal + Astugenal) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Burzynski Research Institute
Primary completion
Feb 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Objective Response
4; 5; 12; 10
SECONDARY
Percentage of Participants Who Survived
70.0; 50.0; 40.0; 35.0; 30.0; 22.5

Summary

RATIONALE: Current therapies for adults with persistent or recurrent brain 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 adults with persistent or recurrent brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
  • Tumor must be at least 5 mm
  • Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • 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/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 severe heart disease
  • 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

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No serious active infections or fever
  • No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry)

Radiotherapy:

  • At least 8 weeks since prior radiotherapy

Surgery:

  • Must recover from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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