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.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The Alvin and Lois Lapidus Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
The Alvin and Lois Lapidus Cancer Institute
ClinicalTrials.gov Identifier:
NCT00333008
First received: May 31, 2006
Last updated: September 25, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Diffuse Large B Cell Lymphoma
Lymphoma, Non-Hodgkin
Drug: Doxil
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Prednisone
Drug: Rituximab
Drug: Pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Alvin and Lois Lapidus Cancer Institute:

Primary Outcome Measures:
  • Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
  • Efficacy: tumor evaluations every three (q 3) cycles

Estimated Enrollment: 27
Study Start Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00333008

Contacts
Contact: Pam Nickoles, RN, BSN 410-601-0729 pnickole@lifebridgehealth.org
Contact: Judy Bosley, RN, BSN 410-601-4392 jbosley@lifebridgehealth.org

Locations
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Pam Nickoles, RN, BSN    410-601-0729    pnickole@lifebridgehealth.org   
Contact: Judy Bosley, RN, BSN    410-601-4392    jbosley@lifebridgehealth.org   
Principal Investigator: Stephen Noga, MD, PhD         
Northwest Hospital Center Recruiting
Randallstown, Maryland, United States, 21133
Contact: Pam Nickoles, RN, BSN    410-601-0729    pnickole@lifebridgehealth.org   
Contact: Judy Bosley, RN, BSN    410-601-4392    jbosley@lifebridgehealth.org   
Principal Investigator: Stephen Noga, MD, PhD         
Sponsors and Collaborators
The Alvin and Lois Lapidus Cancer Institute
Ortho Biotech Products, L.P.
Investigators
Principal Investigator: Stephen Noga, MD, PhD Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00333008     History of Changes
Other Study ID Numbers: LY-012006
Study First Received: May 31, 2006
Last Updated: September 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by The Alvin and Lois Lapidus Cancer Institute:
Diffuse Large B Cell Lymphoma
CDOP
Dose Dense
Anne Arbor Stage I-IV
Any IPI score

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014