Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial