Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

NCT00003505 | Withdrawn Phase 2

• 2 other identifiers: BC-LY-12CDR0000066545
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 primary central nervous system lymphoma.

Conditions

Primary Central Nervous System Lymphoma

Interventions

antineoplaston A10 DRUG

antineoplaston AS2-1 DRUG

alternative product therapy PROCEDURE

biological therapy PROCEDURE

biologically based therapies PROCEDURE

cancer prevention intervention PROCEDURE

complementary and alternative therapy PROCEDURE

differentiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists * Measurable tumor by MRI or CT scan * Tumor must be greater than 2 cm in largest diameter PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC greater than 2,000/mm\^3 * Platelet count greater than 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 history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No cardiac insufficiency * No hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 4 weeks after study participation * No serious infection requiring antibiotics, antifungals, or antivirals PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulatory agents (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: * Concurrent corticosteroids allowed * Must be on stable dose for at least 4 weeks prior to study entry Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No prior antineoplastons

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

MeSH Terms

Interventions

antineoplaston A10; antineoplaston AS 2-1; Biological Therapy; Complementary Therapies

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Last Updated: July 10, 2013

Record last verified: 2006-10

Locations

US (1)