Clinical trial NCT00003508: Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Official title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Mesothelioma
Keywords: advanced malignant mesothelioma
recurrent malignant mesothelioma
Lead sponsor: Burzynski Research Institute
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.

Detailed description: Advanced Mesothelioma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with advanced Mesothelioma, 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 patients with advanced Mesothelioma.
* To determine objective response, tumor size is measured utilizing physical examination and radiologic studies, 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists

  * Evidence of disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 1 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 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
* Hepatic function adequate

Renal:

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

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* Not at high medical or psychiatric risk
* No nonmalignant systemic disease
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents

Primary outcomes:
measure: Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
timeFrame: 109 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Burzynski Clinic
state: Texas
Study officials:
affiliation: Burzynski Research Institute
name: Stanislaw R. Burzynski, MD, PhD
role: STUDY_CHAIR
References:
citation: Preliminary findings on the use of targeted therapy in combination with sodium phenylbutyrate in advanced malignant mesothelioma: A strategy for improved survival. Journal of Cancer Therapy. 2014; 5:1127-1144.
citation: Burzynski SR, Lewy RI, Axler M, Janicki TJ.Treatment of malignant mesothelioma (MM) with sodium phenylbutyrate.Presented at the 15th International Congress on Anti-Cancer Treatment; February 9-12, 2004, Paris, France.