Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

NCT ID: NCT00003502

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

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 stage II, stage III, or stage IV mantle cell lymphoma.

Detailed Description

OBJECTIVES:

• Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.
• Evaluate the response to, 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 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for the third and fourth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Conditions

Contiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Mantle Cell Lymphoma; Recurrent Mantle Cell Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

antineoplaston A10

Intervention Type: DRUG

antineoplaston AS2-1

Intervention Type: DRUG

alternative product therapy

Intervention Type: PROCEDURE

biological therapy

Intervention Type: PROCEDURE

biologically based therapies

Intervention Type: PROCEDURE

cancer prevention intervention

Intervention Type: PROCEDURE

complementary and alternative therapy

Intervention Type: PROCEDURE

differentiation therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy
• Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC greater than 2000/mm^3
• Platelet count greater than 20,000/mm^3

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:

• Creatinine no greater than 2.5 mg/dL
• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No hypertension
• No history of congestive heart failure
• No history of cardiovascular conditions that contraindicate high dosages of sodium

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No serious active infections requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic agent

Endocrine therapy:

• At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)
• No concurrent dexamethasone, prednisone, or other corticosteroids

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No prior antineoplaston therapy
• No concurrent antibiotics, antifungals, or antivirals

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burzynski Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Stanislaw R. Burzynski, MD, PhD

Role: STUDY_CHAIR

Burzynski Research Institute

Locations

Burzynski Clinic

Houston, Texas, United States

Countries

United States

Other Identifiers

CDR0000066542

Identifier Type: REGISTRY

Identifier Source: secondary_id

BC-LY-9

Identifier Type: -

Identifier Source: org_study_id