combination chemotherapy in treating patients with relapsed or refractory hodgkin's lymphoma

Conditions: Lymphoma

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy * core biopsy is acceptable if adequate tissue is obtained for primary diagnosis and immunophenotyping * bone marrow biopsy is not acceptable as sole means of diagnosis * measurable disease * tumor mass greater than 1 cm patient characteristics: age: * any age hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2.0 mg/dl unless history of gilbert's disease * ast no greater than 2 times upper limit of normal renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * lvef at least 45% by muga (for patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m\^2) other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: * no prior gemcitabine, vinorelbine, or doxorubicin hcl liposome * no other concurrent chemotherapy endocrine therapy: * no concurrent hormones except for nondisease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure * no concurrent dexamethasone or other steroidal antiemetics

Keywords: recurrent adult hodgkin lymphoma recurrent/refractory childhood hodgkin lymphoma