|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
St. Jude Children's Research Hospital |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00187070 |
Purpose
The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed approach, and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma
| Condition | Intervention |
|---|---|
|
Lymphoma, Large Cell Lymphoma, Non-Hodgkin |
Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide,
Vinblastine Procedure: Stem cell transplant, Radiation: Radiation Therapy |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Large Cell Lymphoma, Pilot Study III |
| Enrollment: | 8 |
| Study Start Date: | December 1997 |
| Study Completion Date: | July 2001 |
| Primary Completion Date: | July 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide,
Vinblastine
See Detailed Description section for details of treatment interventions.
Procedure: Stem cell transplant,
See Detailed Description section for details of treatment interventions.
Radiation: Radiation Therapy
See Detailed Description section for details of treatment interventions.
|
Secondary objectives will include documenting the toxicity associated with the treatment regimen, and to estimate the response rates and survival of participants with large cell lymphoma treated on this protocol.
Patients will be treated with induction, consolidation, and maintenance treatment.
Induction
MIED chemotherapy - High dose methotrexate, ifosfamide, etoposide, and dexamethasone for 2 cycles.
High-dose methotrexate 8 gm/m2 on Day 1 with leucovorin rescue Ifosfamide 2 gm/m2/day on days 2-4 (total of 3 days) Etoposide (VP-16) 200 mg/m2/day on Days 2-4 (total of 3 days) Dexamethasone 40 mg/m2/day IV on days 1-4 (given IV or PO daily x 4) Intrathecal MHA, age adjusted dosages.
Consolidation
COPADM chemotherapy for 2 cycles - cyclophosphamide, vincristine, prednisone, adriamycin, high-dose methotrexate
COPAM#1 High dose methotrexate (HD MTX) 5 gm/m2 IV over 4 hours on Day 1 with leucovorin rescue; Doxorubicin 60 mg/m2 IV over 6 hours on Day 2, Vincristine 2.0 mg/m2 (2.0 mg max) Day 1, Cyclophosphamide 500 mg/m2/day (divided every 12 hours) Days 2-4, Prednisone 60 mg/m2 (divided bid) Days 1-5, Intrathecal MHA, age adjusted dosages.
COPADM#2 - like COPADM#1 except: 1. cyclophosphamide dose increased to 1 gm/m2/day divided every 12 hours on Days 2-4, and 2. second dose of vincristine given on Day 6.
DAC chemotherapy x 1 cycle - Dexamethasone, cytarabine, and carboplatin
Carboplatin (AUC of 8) Day 1; Ara-C 2 gm/m2/dose q12 x 2 Day 2 Dexamethasone 40 mg/m2/day Days 1-4; ITMHA dose age adjusted.
Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide
Involved field radiation to the primary tumor will be given over 3-4 weeks. Participants with CNS disease at diagnosis will also receive cranial irradiation.
Maintenance chemotherapy
Vinblastine 6 mg/m2 IV weekly for one year
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| St. Jude Children's Reaearch Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | John T. Sandlund, M.D. | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St.Jude Children's Research Hospital ( John T. Sandlund , M.D./Principal Investigator ) |
| Study ID Numbers: | LCLIII |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00187070 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Prednisone Trimethoprim Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Trimethoprim-Sulfamethoxazole Combination Vinblastine Cyclophosphamide Hormones Etoposide phosphate Lymphoma, B-Cell |
Antimalarials Methotrexate Lymphoma, Large-cell Alkylating Agents Lymphoma Etoposide Dexamethasone acetate Cytarabine Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Sulfamethoxazole Vincristine Anti-Infective Agents, Urinary Antimitotic Agents |
|
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Vinblastine Renal Agents Hormones Antimalarials Antiparasitic Agents Therapeutic Uses |
Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Anti-Infective Agents, Urinary Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites |
