NCT Number: NCT00006125
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
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.
Looking for future studies?
Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, Puerto Rico
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Topotecan Hydrochloride
DrugPrimary outcomes
-
Response rate
Time frame: Up to 5 years
Secondary outcomes
-
Time to progression
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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)
Important dates
- Study start
- 2000
- Primary completion
- 2006
- First posted
- Jan 27, 2003
- Registry last updated
- Jul 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
NCT00278408
Burkitt Lymphoma, DNA Virus Infections
Copenhagen, Denmark
View Trial DetailsInvestigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
NCT00243087
Burkitt Lymphoma, DNA Virus Infections
Washington D.C., District of Columbia, United States
View Trial DetailsCardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin
NCT00577798
Blood Protein Disorders, Burkitt Lymphoma
Omaha, Nebraska, United States
View Trial DetailsPhysician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
NCT00002520
Bladder Cancer, Breast Cancer
Philadelphia, Pennsylvania, United States
View Trial Details