Lymphoma
Conditions
Keywords
recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, anaplastic large cell 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 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.
Interventions
DRUGdoxorubicin hydrochloride
DRUGtopotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma of one of the following subtypes: * Follicular center lymphoma, grade 3 * Diffuse large B-cell lymphoma * Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma * Burkitt's lymphoma * High grade B-cell lymphoma, Burkitt-like * Anaplastic large cell lymphoma, CD30+ cell type * Anaplastic large cell lymphoma, T-cell type * Anaplastic large cell lymphoma, null-cell type * Anaplastic large cell lymphoma, Hodgkin's like * Bidimensionally measurable disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL history of Gilbert's Disease * AST no greater than 2.5 times upper limit of normal Renal: * Creatinine normal Cardiovascular: * LVEF at least 45% by MUGA or echocardiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Greater than 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) * No greater than 96 mg/m2 mitoxantrone * No greater than 400 mg/m2 prior doxorubicin or combined total doxorubicin and mitoxantrone * No prior camptothecins * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except steroids for adrenal failure or hormones given for nondisease conditions (e.g., insulin for diabetes) * No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: * Greater than 3 weeks since prior radiotherapy * No concurrent radiotherapy except whole brain irradiation for documented CNS disease Surgery: * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | Up to 5 years |
Countries
Puerto Rico, United States
Outcome results
None listed