Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00003502

Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Burzynski Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGantineoplaston A10
DRUGantineoplaston AS2-1
PROCEDUREalternative product therapy
PROCEDUREbiological therapy
PROCEDUREbiologically based therapies
PROCEDUREcancer prevention intervention
PROCEDUREcomplementary and alternative therapy
PROCEDUREdifferentiation therapy

Timeline

First posted
2003-01-27
Last updated
2013-07-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003502. Inclusion in this directory is not an endorsement.