Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma |
- Response rate by laboratory results at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1996 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stanislaw R. Burzynski, Burzynski Clinic |
| ClinicalTrials.gov Identifier: | NCT00003511 History of Changes |
| Other Study ID Numbers: | CDR0000066554, BC-MM-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 21, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013