Research Activities
The following clinical trials were conducted in this year.
Phase I and I/II trials
1. CPT-11/etoposide for relapsed non-Hodgkin’s lymphoma
2. dose escalated CHOP for aggressive non-Hodgkin's lymphoma
Phase II trials
1. IDEC-C2B8 (monoclonal antibody against CD20) for low grade non-Hodgkin's lymphoma
2. NS-075 (high dose cytarabine) for acute myeloid leukemia
3. J COG-LSG 16 for lymphoblastic lymphoma or acute lymphoblastic leukemia
4. JCOG-LSG 14 for Hodgkin's disease
5. JCOG-LSG 17 for standard-risk non-Hodgkin's lymphoma
6. JCOG-LSG 19/20 randomized study for high-risk non-Hodgkin's lymphoma
7. auto BMT for relapsed malignant lymphoma
Phase III trials
1. JCOG-LSG 13/mLSG 8 for multiple myeloma
2. JALSG (Japan Adult Leukemia Study Group) AML 75 for acute myeloid leukemia
3. JCOG-randomized study of autoBMT/ conventional dose chemotherapy for breast cancer
The NCCHE has more cases enrolled into JCOG-LSG trials than the NCCH, Tokyo, and we rank first among the institutions holding membership in the fields of HodgkinÕs disease (LSG14), non-HodgkinÕs lymphoma (LSG17 and LSG19/20) and multiple myeloma (LSG13/mLSG8).
New Developments
In chemotherapy of patients with non-HodgkinÕs lymphoma (intermediate or high grade), the third generation therapy consists of a number of active drugs (MACO-P, PROMACE-CYTABOM, etc.) was not found to be therapeutically effective, and CHOP therapy (the first generation chemotherapy) was still assessed to be the standard treatment, indicating the importance of developing new regimens. As a result, we conducted a single institutional phase I, II trial of high dose CHOP therapy and determined the maximum tolerated dose of doxorubicin (DOX) and cyclo-phosphamide (CPM), i.e., 70 mg/m2 of DOX and 1250 mg/m2 of CPM without G-CSF administration, and 70 mg/m2 and 2250 mg/m2 of CPM with administration of G-CSF. Based on this result, JCOG-LSG started a new randomized phase II study (LSG19/20: biweekly CHOP vs. high CHOP).
Statistics
| Protocol | No. of pts | |
| Hodgkin's Disease | LSG 14 | 3 |
| non-Hodgkin's Lymphoma | LSG 16 | 1 |
| LSG 17 | 14 | |
| LSG 19/20 | 4 | |
| Multiple Myeloma | LSG 13/mLSG 8 | 3 |
| Acute Myeloid Leukemia | JALSG AML 95 | 2 |
| Bone Marrow Transplantation | 4 |
(K. Ito)