Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas

National Cancer Institute (NCI) logo

National Cancer Institute (NCI)

Status and phase

Completed
Phase 2

Conditions

Lymphoma, Large-Cell, Diffuse
Lymphoma, Small Noncleaved-Cell
Burkitt Lymphoma

Treatments

Drug: granulocyte-macrophage colony stimulating factor (GM-CSF)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00001237
89-C-0041
890041

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

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Data sourced from clinicaltrials.gov

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