Trials / Completed
CompletedNCT00001237
Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (planned)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | granulocyte-macrophage colony stimulating factor (GM-CSF) |
Timeline
- Start date
- 1989-03-01
- Completion
- 2000-04-01
- First posted
- 2002-12-10
- Last updated
- 2008-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00001237. Inclusion in this directory is not an endorsement.