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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001237 |
Purpose
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I & II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Burkitt Lymphoma Lymphoma, Large-Cell, Diffuse Lymphoma, Small Noncleaved-Cell |
Drug: granulocyte-macrophage colony stimulating factor (GM-CSF) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 1989 |
| Estimated Study Completion Date: | April 2000 |
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I & II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
High Risk Protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas except those with:
a) Minimal extra-abdominal tumor as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or except those with b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted) and a serum LDH level less than 1.5 times upper limit of normal (NIH patients less than 350 U/L).
All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a serum LDH level greater than 1.5 times the upper limit of normal (NIH patients, greater than 350 U/L), regardless of the clinically documented extent of disease.
All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with testicular involvement.
Low risk protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a) minimal extra-abdominal disease as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted for gastrointestinal disease) and a serum LDH level less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L).
No patients with lymphoblastic lymphomas, low grade or follicular lymphomas.
No patients with peripheral T cell lymphomas that do not fall into the category of anaplastic large cell lymphoma.
No patients with a previously documented lymphoma or histological evidence of co-existing lymphoma of other histology.
No patients who have been previously treated with chemotherapy or radiotherapy.
No patients with HIV infection.
No patients above the age of 60 years.
No patients with a history of inherited or non-HIV acquired immunodeficiency syndromes.
Contacts and Locations More Information
| Study ID Numbers: | 890041, 89-C-0041 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001237 |
| Health Authority: | United States: Federal Government |
|
Burkitt's Lymphoma GM-CSF High-Grade |
|
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Herpesviridae Infections Virus Diseases Lymphoma, B-Cell Lymphoma, large-cell Burkitt's lymphoma Lymphatic Diseases |
B-cell lymphomas Burkitt Lymphoma Epstein-Barr Virus Infections DNA Virus Infections Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases Tumor Virus Infections Neoplasms, Experimental |
