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


Phase 2
N/A
N/A
Not Enrolling
Both
Burkitt Lymphoma, Lymphoma, Large-Cell, Diffuse, Lymphoma, Small Noncleaved-Cell

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

890041

NCT ID:

NCT00001237

Start Date:

March 1989

Completion Date:

April 2000

Related Keywords:

  • Burkitt Lymphoma
  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, Small Noncleaved-Cell
  • Burkitt's Lymphoma
  • GM-CSF
  • High-Grade
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892