Large Cell Lymphoma Pilot Study III
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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Large Cell Lymphoma, Pilot Study III |
- To demonstrate the feasibility of delivery of a multiagent chemotherapy regimen which features a shorter, more direct approach, and includes a phase that incorporates hematopoietic stem cell support for children with large cell lymphoma. [ Time Frame: July 2001 ] [ Designated as safety issue: Yes ]
| 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.
|
Detailed Description:
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:
- Patient must be previously untreated, except for steroids or emergency radiation therapy.
- Patient must be less than or equal to 18 years of age.
- Patient must have a histologic diagnosis of large cell Non-Hodgkin lymphoma.
- The immunophenotype of tumor cells must be either T-cell or non-B-cell, non-T-cell.
Exclusion Criteria:
- Participants with B-cell immunophenotype NHL.
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
Additional Information:
No publications provided
| Responsible Party: | John T. Sandlund , M.D./Principal Investigator, St.Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00187070 History of Changes |
| Other Study ID Numbers: | LCLIII |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 6, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Cytarabine Methotrexate Ifosfamide Dexamethasone Doxorubicin Etoposide |
Prednisone Vinblastine Vincristine Carboplatin Trimethoprim-Sulfamethoxazole Combination Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 16, 2013