|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00365274 |
Purpose
RATIONALE: Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving SGN-30 together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving SGN-30 together with combination chemotherapy works in treating patients with newly diagnosed anaplastic large cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: Monoclonal antibody SGN-30 Drug: Cyclophosphamide Drug: Doxorubicin hydrochloride Drug: Prednisone Drug: Vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma |
| Enrollment: | 6 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SGN-30 + Combination Chemotherapy
SGN-30 3 weekly intravenous (IV) doses of 12 mg/kg; Cyclophosphamide IV 750 mg/m^2, Doxorubicin IV 50 mg/m^2 and Vincristine 1.4 mg/m^2 IV Day 1 of 3 week cycle; 100 mg/day orally for 5 days.
|
Biological: Monoclonal antibody SGN-30
3 weekly intravenous doses of 12 mg/kg
Drug: Cyclophosphamide
750 mg/m^2 Day 1 by vein over about 4 hours, once every 3 weeks
Other Names:
Drug: Doxorubicin hydrochloride
50 mg/m^2 day 1 (can be given either as bolus or as continuous infusion) by vein over about 4 hours, once every 3 weeks
Other Names:
Drug: Prednisone
100 mg tablet by mouth once a day for 5 days starting Day 1
Drug: Vincristine sulfate
1.4 mg/m^2 (maximum 2 mg) day 1 by vein over about 4 hours, once every 3 weeks
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large cell kinase (ALK) status (positive vs negative).
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
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| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Michelle Fanale, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Michelle A. Fanale, MD / Assistant Professor, M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00365274 History of Changes |
| Other Study ID Numbers: | MDA-2005-0627, P30CA016672, MDA-2005-0627, NCI-7372, CDR0000492803 |
| Study First Received: | August 16, 2006 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
anaplastic large cell lymphoma |
|
Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, T-Cell Antibodies Antibodies, Monoclonal Cyclophosphamide |
Doxorubicin Prednisone Vincristine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |