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Phase 2 N=20 Treatment

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

Mixed Gliomas

Enrolled (actual)
20
Serious AEs
40.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Participants With Objective Response — 3; 0; 4; 10 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Atengenal (Drug); Astugenal (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Burzynski Research Institute
Primary completion
Aug 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Objective Response
3; 0; 4; 10
SECONDARY
Percentage of Participants Who Survived
65.0; 55.0; 30.0; 30.0; 20.0; 15.0

Summary

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy
  • Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry
  • Must have received and failed standard therapy
  • Tumor must be at least 5 mm

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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No severe lung disease
  • No severe chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No other severe medical illness
  • No nonmalignant systemic disease
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since immunotherapy

Chemotherapy:

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

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression)

Surgery:

  • Fully recovered from prior surgery

Other:

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

Data sourced from ClinicalTrials.gov (NCT00003473). 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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