Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory Waldenstrom's macroglobulinemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma 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 Macroglobulinemia of Waldenstrom |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 1998 |
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory Waldenstrom's macroglobulinemia.
- 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 antineoplastons A10 and 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 or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Tumors are measured every 2 months the first year and every 3 months the second year.
PROJECTED ACCRUAL: Approximately 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 confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
- Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination)
Biochemical evidence of Waldenstrom's macroglobulinemia
- Abnormal proteins in serum and urine
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- No renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious 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 active infection
- No non-malignant systemic disease
- Not a high medical or psychiatric risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunomodulating agent
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy
- No concurrent antineoplastic agents
Endocrine therapy:
- See Disease Characteristics
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No prior antineoplastons
- Prior cytodifferentiating agents allowed
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
| ClinicalTrials.gov Identifier: | NCT00003512 History of Changes |
| Other Study ID Numbers: | CDR0000066555, BC-MW-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 16, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
refractory multiple myeloma Waldenstrom macroglobulinemia |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma Waldenstrom Macroglobulinemia Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 21, 2013