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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: topotecan hydrochloride; Drug: doxorubicin hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006125

CALGB-59906

CDR0000068140 (Registry Identifier)

CLB-59906

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Doxorubicin + topotecan

Experimental group

Description:

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.

Treatment:

Drug: doxorubicin hydrochloride

Drug: topotecan hydrochloride