Mesothelioma Clinical Trials
Antineoplaston
Therapy in Treating Patients With Advanced
Mesothelioma
This study is currently
recruiting patients.
RATIONALE: Antineoplastons are
naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer
cells.
PURPOSE: This phase II trial studies the effectiveness of
antineoplaston therapy in treating patients who have advanced
mesothelioma.
| Condition |
Treatment or Intervention |
advanced malignant
mesothelioma
recurrent malignant mesothelioma
|
Drug: antineoplaston
A10
Drug: antineoplaston
AS2-1
Procedure: alternative product
therapy
Procedure: biological response
modifier therapy
Procedure: biologically
based therapies
Procedure: cancer
prevention
intervention
Procedure: complementary and
alternative
therapy
Procedure: differentiation
therapy
|
This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its
safety.
Study Type: Interventional
Study
Design: Treatment
Official Title: Phase II Study of
Antineoplastons A10 and AS2-1 in Patients With Stage IV
Mesothelioma
Further Study Details:
OBJECTIVES:
- Provide treatment with antineoplastons A10 and AS2-1 to
patients with stage IV mesothelioma.
- Describe the response to, tolerance to, and side effects
of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of
antineoplaston A10 and antineoplaston AS2-1 IV six times per
day until the maximum dose is reached.
Treatment continues for at least 3 months in the absence of
disease progression or unacceptable toxicity. After 3 months,
patients with stable or responding disease may continue
treatment. Patients achieving complete response (CR) continue
treatment for at least 8 months beyond CR.
Patients are followed every 2 months for 1 year and then
every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be
accrued for this study.
Ages Eligible for Study: 1 Year and above,
Genders Eligible for Study: Both
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:
Performance status:
Life expectancy:
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
| 
