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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00059839 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: vinblastine Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2003 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I (consolidation therapy): Active Comparator
In courses 1-3, patients receive doxorubicin IV over 15 minutes, vincristine IV, and methotrexate intrathecally (IT) on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin, vincristine, prednisone, and mercaptopurine as in courses 1-3. In courses 6-15, patients receive vincristine, prednisone, and mercaptopurine as in courses 1-3 and methotrexate IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: mercaptopurine
Given by mouth
Drug: methotrexate
Given IV and intrathecally
Drug: prednisone
Given by mouth
Drug: vincristine sulfate
Given IV
|
|
Arm II (consolidation therapy): Experimental
In courses 1-3, patients receive doxorubicin, methotrexate IT, prednisone, and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin, prednisone, and mercaptopurine as in arm I and vinblastine as in arm II (courses 1-3). In courses 6-15, patients receive prednisone and mercaptopurine as in arm I, vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: mercaptopurine
Given by mouth
Drug: methotrexate
Given IV and intrathecally
Drug: prednisone
Given by mouth
Drug: vinblastine
Given IV
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Patients then begin consolidation therapy on day 43.
Consolidation therapy: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive course-specific regimens.
Arm II: Patients receive course-specific regimens.
In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed advanced anaplastic large cell lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 159 Study Locations| Study Chair: | Jacqueline Kraveka, DO | Medical University of South Carolina |
More Information
| Study ID Numbers: | CDR0000298777, COG-ANHL0131 |
| Study First Received: | May 6, 2003 |
| Last Updated: | January 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00059839 |
| Health Authority: | United States: Federal Government |
|
anaplastic large cell lymphoma |
|
Prednisone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Vincristine Vinblastine 6-Mercaptopurine Doxorubicin Folic Acid Lymphoma, B-Cell Lymphoma, large-cell |
Lymphatic Diseases Lymphoma, T-Cell B-cell lymphomas Lymphoma, Large-Cell, Anaplastic Methotrexate Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
|
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Antibiotics, Antineoplastic Hormones Therapeutic Uses Abortifacient Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Tubulin Modulators Antirheumatic Agents Antineoplastic Agents, Phytogenic |
