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Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00006125   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes

August 3, 2000
July 23, 2008
July 2000
 
 
 
Complete list of historical versions of study NCT00006125 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
A Phase II Study of Sequential Doxorubicin and Topotecan (Dox/Topo) in Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma (NHL)

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.

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.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study over 2.5 years.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Drug: doxorubicin hydrochloride
  • Drug: topotecan hydrochloride
 
Smith SM, Johnson JL, Niedzwiecki D, Eder JP, Canellos G, Cheson BD, Bartlett NL, Cancer and Leukemia Group B. Sequential doxorubicin and topotecan in relapsed/refractory aggressive non-Hodgkin's lymphoma: results of CALGB 59906. Leuk Lymphoma. 2006 Aug;47(8):1511-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00006125
 
CDR0000068140, CLB-59906
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Nancy L. Bartlett, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP