NCT00006125

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

A Phase II Study of Sequential Doxorubicin and Topotecan (Dox/Topo) in Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and topotecan in treating patients who have relapsed or refractory intermediate-grade or high-grade non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Determine the response rate and time to progression in patients with relapsed or refractory intermediate or high grade non-Hodgkin's lymphoma treated with doxorubicin and topotecan. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive doxorubicin IV over 5-10 minutes on day 1 and topotecan IV over 30 minutes on days 3-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years and annually for the next 3 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride
DRUG	topotecan hydrochloride

Timeline

• Start date: 2000-07-01
• Primary completion: 2006-08-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

76 sites across 2 countries: United States, Puerto Rico