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Phase 2 N=19 Treatment

Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

Adult Brain Tumor

Enrolled (actual)
19
Serious AEs
57.9%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Objective Response — 3; 1; 5; 9 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
Oct 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Objective Response
3; 1; 5; 9
SECONDARY
Percentage of Participants Who Survived
68.4; 52.6; 36.8; 26.3; 26.3; 21.1

Summary

RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma
  • Tumor subtotally resected or biopsied prior to therapy
  • Evidence of residual tumor by MRI scan performed within two weeks prior to study entry
  • No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months

Hematopoietic:

  • WBC at least 1,500/mm^3
  • Platelet count at least 50,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

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

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No renal failure

Cardiovascular:

  • No prior congestive heart failure
  • No coronary artery disease
  • No myocardial infarction within the past year
  • No angina requiring medication
  • No uncontrolled hypertension

Pulmonary:

  • No moderate to 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 active infection
  • No other concurrent serious disease
  • No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • No prior myelosuppressive chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

  • No prior myelosuppressive radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior surgery

Other:

  • No prior cytodifferentiating agents
  • No prior antineoplaston therapy
  • No other concurrent antineoplastic agents
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003537). 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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