Multiple Myeloma Clinical Trial
Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Summary
Current therapies for Multiple Myeloma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Multiple Myeloma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Multiple Myeloma.
Full Description
Multiple Myeloma 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 Multiple Myeloma, 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 Multiple Myeloma.
To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, 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 and biochemically confirmed recurrent or progressing multiple myeloma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
At least one standard first line therapy failure
No localized plasmacytoma or plasmacytosis limited to the bone marrow
Evidence of tumor by MRI or CT scan
Presence of myeloma proteins in serum and urine, including Bence-Jones proteins
PATIENT CHARACTERISTICS:
Age:
18 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
No hepatic insufficiency
Renal:
Creatinine no greater than 2.5 mg/dL
No renal problems
No renal conditions that contraindicate high dosages of sodium
Cardiovascular:
No chronic heart failure
No uncontrolled hypertension
No history of congestive heart failure
No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
No severe lung disease, such as chronic obstructive pulmonary disease
Other:
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study
No serious medical or psychiatric disorders
No active infections
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior immunotherapy and recovered
No concurrent immunomodulating agents
Chemotherapy:
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
No concurrent antineoplastic agents
Endocrine therapy:
Concurrent corticosteroids allowed
Radiotherapy:
At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks)
Surgery:
Must be recovered from prior surgery
Other:
Prior cytodifferentiating agent allowed
No prior antineoplaston therapy
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There is 1 Location for this study
Houston Texas, 77055, United States
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