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NCT00003479
Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma
Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Ependymoma in 9 participants. Terminated before completion.
1 October 2000
Quick facts
| Lead sponsor | Burzynski Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 July 1966 |
| Primary completion | 1 October 2000 |
| Estimated completion | 1 October 2000 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Antineoplaston therapy (Atengenal + Astugenal) — full drug profile →
Conditions studied
- Ependymoma — all drugs for Ependymoma →
Sponsor
Burzynski Research Institute
Who can join
Adults 6 Months to 99, any sex, with Ependymoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With Objective Response
Time frame: 12 months
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD
Sponsor's own description
RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma . PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00003479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Antineoplaston therapy (Atengenal + Astugenal)
Trials testing the same drug.
- NCT00003512 — Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia · Phase 2 · withdrawn
- NCT00003498 — Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma · Phase 2 · terminated
- NCT00003522 — Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine · Phase 2 · terminated
- NCT00003513 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma · Phase 2 · terminated
- NCT00003515 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors · Phase 2 · terminated
Other recruiting trials for Ependymoma
Currently open trials in the same condition.
- NCT06521567 — A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer · Phase 1, PHASE2 · active not recruiting
- NCT06193759 — Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT) · Phase 1 · recruiting
- NCT06161519 — PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications · Phase 1, PHASE2 · recruiting
- NCT05259605 — Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 202 · recruiting
- NCT05672043 — Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China · recruiting
Other Burzynski Research Institute trials
Trials by the same sponsor.
- NCT00003512 — Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia · Phase 2 · withdrawn
- NCT00003498 — Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma · Phase 2 · terminated
- NCT00003522 — Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine · Phase 2 · terminated
- NCT00003513 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma · Phase 2 · terminated
- NCT00003515 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00003479 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Burzynski Research Institute
- Last refreshed: 18 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00003479.
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