Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02988726
Other study ID # BC-BT-19
Secondary ID
Status Terminated
Phase Phase 2
First received November 22, 2016
Last updated July 24, 2017
Start date March 1999
Est. completion date August 2001

Study information

Verified date July 2017
Source Burzynski Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma 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 a recurrent/residual Neurofibroma or Schwannoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.


Description:

OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/residual Neurofibroma or Schwannoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in adults with a recurrent/residual Neurofibroma or Schwannoma, as measured by an objective response to therapy (complete response, partial response or stable disease).

- To determine the safety and tolerance of Antineoplaston therapy in adults with a recurrent/residual Neurofibroma or Schwannoma.

- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date August 2001
Est. primary completion date August 2001
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Histologically confirmed incurable Neurofibroma or Schwannoma. Histological confirmation is waived for tumor location where biopsy cannot be safely performed.

- There will be no exclusion based on multifocality, or leptomeningeal or systemic metastases.

- The tumor must be at least 5 mm in size.

- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI performed no more than 14 days before the beginning of therapy.

- Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agents are eligible.

- Patients who did not receive standard therapy are eligible.

- Patients may be male or female. If female, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If male, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.

- Patient must sign the Informed Consent Document indicting an awareness of the experimental nature of this study. In the event the patient has impairment of higher intellectual function, for example, aphasia, the the patient's legal next of kin or legal guardian must sign the Informed Consent Document indicating an awareness of the experimental nature of the study.

- Patient must fully recover from the operative procedure and have life expectancy of two months or more. The patient's performance status should be consistent with outpatient therapy, i.e., 60% - 100% Karnofsky. The use of corticosteroids is permitted to reduce symptoms attributed to cerebral edema. It is recommended that the smallest dose be used compatible with the preservation of optimal neurological function.

- Minimal hematological parameters include a hemoglobin of at least 9 g/dL, a white blood count of at least 1500, and a platelet count of at least 50,000.

- Patients with no evidence of hepatic or renal insufficiency; a total serum bilirubin and creatinine not higher than 2.5 mg/dL; and a SGOT and SGPT not higher than 5 times the upper limit of normal.

- Patients must recover from the adverse effect of previous therapy. At least eight weeks must have lapsed since the last dose of radiation therapy and at least four weeks must have lapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.

Exclusion Criteria:

- Failure to meet all inclusion criteria.

- Patient either pregnant or breast feeding an infant.

- Patient is a high medical or psychiatric risk, having non-malignant systemic disease, which would, in the opinion of the investigator, make therapy with an investigational agent unwise.

- Patient is incompetent to give informed consent to treatment. However, the patient may be admitted if a legally appointed guardian gives consent.

- Presence of an active infection.

- Patients with known chronic heart failure and serious lung disease, such as severe COPD.

- Patients with hypertension are excluded unless the hypertension is adequately controlled.

- Patients who have had prior Antineoplaston treatment should be excluded from this protocol.

- Patients who do not have adequate hepatic function.

Study Design


Intervention

Drug:
Antineoplaston therapy (Atengenal + Astugenal)
Adults with a recurrent/residual Neurofibroma or Schwannoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Locations

Country Name City State
United States Burzynski Clinic Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Objective Response 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. 12 months
Secondary Percentage of Participants who Survived 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06036394 - Artificial Intelligence in CNS Radiation Oncology
Withdrawn NCT05222165 - Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations Phase 1/Phase 2
Recruiting NCT03838042 - INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies Phase 1/Phase 2
Recruiting NCT05300113 - Artificial Intelligence Neuropathologist
Completed NCT04334239 - Effectiveness of Care in Certified Cancer Centres in Germany
Completed NCT03434262 - SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors Phase 1
Withdrawn NCT05952687 - Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors Phase 1
Recruiting NCT06322342 - Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent Phase 2
Not yet recruiting NCT06441331 - Phase I Trial to Determine the Dose and Evaluate the PK of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors Phase 1
Recruiting NCT04706676 - Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer N/A
Recruiting NCT04773782 - A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling Phase 1/Phase 2
Active, not recruiting NCT04023669 - Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors Phase 1
Recruiting NCT05982691 - Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
Recruiting NCT04732065 - ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors Phase 1
Active, not recruiting NCT02684838 - Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
Recruiting NCT05480904 - Characterizing Sleep Among Long-term Survivors of Childhood Cancer