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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: doxorubicin hydrochloride
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxorubicin + topotecan<br>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. | Drug: doxorubicin hydrochloride<br> <br> Drug: topotecan hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, anaplastic large cell lymphoma