- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00333008
A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
September 25, 2006 updated by: The Alvin and Lois Lapidus Cancer Institute
Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years.
Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality.
The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients.
Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population.
For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity.
DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome.
In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments.
This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin.
Growth factor will be used for support of acceptable blood counts.
Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL.
If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.
Study Type
Interventional
Enrollment
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pam Nickoles, RN, BSN
- Phone Number: 410-601-0729
- Email: pnickole@lifebridgehealth.org
Study Contact Backup
- Name: Judy Bosley, RN, BSN
- Phone Number: 410-601-4392
- Email: jbosley@lifebridgehealth.org
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital of Baltimore
-
Contact:
- Pam Nickoles, RN, BSN
- Phone Number: 410-601-0729
- Email: pnickole@lifebridgehealth.org
-
Contact:
- Judy Bosley, RN, BSN
- Phone Number: 410-601-4392
- Email: jbosley@lifebridgehealth.org
-
Principal Investigator:
- Stephen Noga, MD, PhD
-
Randallstown, Maryland, United States, 21133
- Recruiting
- Northwest Hospital Center
-
Contact:
- Pam Nickoles, RN, BSN
- Phone Number: 410-601-0729
- Email: pnickole@lifebridgehealth.org
-
Contact:
- Judy Bosley, RN, BSN
- Phone Number: 410-601-4392
- Email: jbosley@lifebridgehealth.org
-
Principal Investigator:
- Stephen Noga, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
- Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
- Previously untreated
- New York Heart Association (NYHA) classification of Class III or better
- Baseline ejection fraction (EF) > 25%
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- Unless attributable to NHL: absolute neutrophil count (ANC) > 1500/uL, platelets > 100,000/uL; hemoglobin > 9.0 g/dl
- Bilirubin < 1.5 mg/dL (unless related to lymphoma)
- Hepatic: transaminases < 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
- Creatinine < 2.5 mg/dl (unless related to lymphoma)
Exclusion Criteria:
- No HIV+ individuals
- No primary central nervous system (CNS) lymphoma
- No pregnant or lactating women
- No serious active infection
- History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
|
Efficacy: tumor evaluations every three (q 3) cycles
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephen Noga, MD, PhD, Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Registration Dates
First Submitted
May 31, 2006
First Submitted That Met QC Criteria
May 31, 2006
First Posted (Estimate)
June 2, 2006
Study Record Updates
Last Update Posted (Estimate)
September 26, 2006
Last Update Submitted That Met QC Criteria
September 25, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Cyclophosphamide
- Rituximab
- Prednisone
- Vincristine
Other Study ID Numbers
- LY-012006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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