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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00006125
First received: August 3, 2000
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: doxorubicin hydrochloride
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Sequential Doxorubicin and Topotecan (Dox/Topo) in Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Study Start Date: July 2000
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxorubicin + topotecan

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 Drug: topotecan hydrochloride

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006125

  Show 76 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Nancy L. Bartlett, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Publications:
Smith SM, Johnson JL, Niedzwiecki D, et al.: Sequential topoisomerase I (topo I) and topoisomerase II (topo II) inhibitors in relapsed/refractory aggressive NHL: results of CALGB 59906, a phase II study of doxorubicin and topotecan. [Abstract] Blood 104 (11): A-2500, 2004.

ClinicalTrials.gov Identifier: NCT00006125     History of Changes
Other Study ID Numbers: CALGB-59906, U10CA031946, CLB-59906, CDR0000068140
Study First Received: August 3, 2000
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult Burkitt lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 30, 2015