NCT00006029

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• 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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma. * Determine the complete and partial response rates of patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Phase I: * Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression. Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation. Cohorts of 3-6 patients receive escalating doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with gemcitabine, vinorelbine, and doxorubicin HCl liposome at the recommended phase II dose. Phase II: * Patients are assigned to 1 of 2 treatment groups. * Group 1: Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome as in phase I. * Group 2: Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome as in group 1. Patients are followed every 6 months for 2 years and then annually for 6 years. PROJECTED ACCRUAL: Approximately 3-100 patients (3-42 for phase I and 20-58 for phase II \[29 per group\]) will be accrued for this study within 3 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	pegylated liposomal doxorubicin hydrochloride
DRUG	vinorelbine tartrate

Timeline

• Start date: 2000-07-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

76 sites across 2 countries: United States, Puerto Rico