Lymphoma
Conditions
Keywords
recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
Brief 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.
Interventions
DRUGgemcitabine hydrochloride
DRUGpegylated liposomal doxorubicin hydrochloride
DRUGvinorelbine tartrate
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | Up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Up to 4 years |
Countries
Puerto Rico, United States
Outcome results
None listed