This trial is active, not recruiting.

Condition multiple myeloma and plasma cell neoplasm
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date April 1996
End date January 2008
Trial size 40 participants
Trial identifier NCT00003511, BC-MM-2, CDR0000066554


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 is studying how well antineoplaston therapy works in treating patients with recurrent or progressive multiple myeloma after treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Response rate by laboratory results at 12 weeks
time frame:

Secondary Outcomes

Survival at 1, 2, and 5 years from the start of treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma
Description OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or progressing multiple myeloma after standard first line therapy. - Describe response, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open label study. Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for the first year and every 3 months for the second year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).