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| Sponsor: | The Alvin and Lois Lapidus Cancer Institute |
|---|---|
| Collaborator: |
Ortho Biotech Products, L.P. |
| Information provided by: | The Alvin and Lois Lapidus Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00333008 |
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 II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Dose Comparison 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 |
| Estimated Enrollment: | 27 |
| Study Start Date: | May 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pam Nickoles, RN, BSN | 410-601-0729 | pnickole@lifebridgehealth.org |
| Contact: Judy Bosley, RN, BSN | 410-601-4392 | jbosley@lifebridgehealth.org |
| 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 | |
| Principal Investigator: | Stephen Noga, MD, PhD | Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute |
More Information
| Study ID Numbers: | LY-012006 |
| Study First Received: | May 31, 2006 |
| Last Updated: | September 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00333008 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Diffuse Large B Cell Lymphoma CDOP Dose Dense Anne Arbor Stage I-IV Any IPI score |
|
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Lymphoma, B-Cell Therapeutic Uses Lymphoma Alkylating Agents Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators |