Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
Data Collection
Burkitt Lymphoma+15
+ DNA Virus Infections
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: March 1, 1989
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cancer Institute (NCI)
Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps