Phase 2 N=13 Treatment

Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors

Childhood CNS Primitive Neuroectodermal Tumor

Bottom Line

View on ClinicalTrials.gov: NCT00003460 ↗

Enrolled (actual)

Serious AEs

76.9%

Results posted

Nov 2016

Primary outcome: Primary: Number of Participants With Objective Response — 3; 1; 1; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Antineoplaston therapy (Atengenal + Astugenal) (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Burzynski Research Institute
Primary completion: Feb 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Objective Response	3; 1; 1; 7	—
SECONDARY Percentage of Participants Who Survived	61.5; 61.5; 53.8; 46.2; 38.5; 38.5	—

Summary

RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primitive neuroectodermal tumors that have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with primitive neuroectodermal tumors that has not responded to standard therapy.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed (except if medically contraindicated) incurable primitive neuroectodermal tumor
Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
Must have received and failed prior standard therapy
Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

6 months to 17 years

Performance status:

Karnofsky 60-100%

Life expectancy:

At least 2 months

Hematopoietic:

WBC at least 2000/mm^3
Platelet count greater than 50,000/mm^3

Hepatic:

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

Renal:

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

Cardiovascular:

No uncontrolled hypertension
No severe heart disease
No history of congestive heart failure
No 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 concomitant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior immunotherapy and recovered
No concurrent immunomodulating agents

Chemotherapy:

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

Surgery:

Not specified

Other:

No prior antineoplaston treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003460). 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.