Malignant Mesothelioma
Conditions
Keywords
advanced malignant mesothelioma, recurrent malignant mesothelioma
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.
Interventions
DRUGAntineoplaston therapy (Atengenal + Astugenal)
Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Sponsors
Burzynski Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable | 109 months | Objective response rate per The International Working Group response criteria (1999): 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 lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm: Experimental: Antineoplaston Therapy Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1. | 8 |
| Arm: Experimental: Antineoplaston Therapy Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1. | 3 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evaluable | 5 |
Baseline characteristics
| Characteristic | Arm: Experimental: Antineoplaston Therapy |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 8.9527 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 2 / 8 |
Outcome results
Primary
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Objective response rate per The International Working Group response criteria (1999): 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 lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
Time frame: 109 months
Population: All patients enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm: Experimental: Antineoplaston Therapy | Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable | Objective Response | 0 participants |
| Arm: Experimental: Antineoplaston Therapy | Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable | Stable Disease | 2 participants |
| Arm: Experimental: Antineoplaston Therapy | Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable | Progressive Disease | 1 participants |
| Arm: Experimental: Antineoplaston Therapy | Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable | Not evaluable | 5 participants |