NCT00003514

Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors

• Status: Withdrawn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 neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.

Detailed description

OBJECTIVES: * Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors. * 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 2 months in the absence of unacceptable 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 for 1 year and then every 3 months for 1 year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Conditions

• Merkel Cell Carcinoma
• Islet Cell Carcinoma
• Neuroendocrine Carcinoma
• Pituitary Tumor

Interventions

Type	Name	Description
DRUG	antineoplaston A10
DRUG	antineoplaston AS2-1
PROCEDURE	alternative product therapy
PROCEDURE	biological therapy
PROCEDURE	biologically based therapies
PROCEDURE	cancer prevention intervention
PROCEDURE	complementary and alternative therapy
PROCEDURE	differentiation therapy

Timeline

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

Locations

1 site across 1 country: United States