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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006125

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2000

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.

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

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

Show 76 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Nancy L. Bartlett, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	CDR0000068140, CLB-59906
Study First Received:	August 3, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00006125 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult Burkitt lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

Doxorubicin
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Topotecan
Lymphoma

ClinicalTrials.gov processed this record on November 22, 2009