Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma
|Esophageal Cancer Lung Cancer Lymphoma||Drug: topotecan hydrochloride Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION|
|Study Start Date:||March 1995|
|Study Completion Date:||September 2000|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Radiosensitization plus Radiotherapy. Topotecan hydrochloride, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).
|Drug: topotecan hydrochloride Radiation: low-LET electron therapy Radiation: low-LET photon therapy|
I. Define the maximum tolerated dose and safety profile of topotecan (TOPO) administered with daily high-dose thoracic radiotherapy to a total of 60 Gy in patients with solid tumor or lymphoma.
II. Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment.
III. Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels.
IV. Evaluate, using Western blot and immunohistochemical stain, the effects of TOPO/radiotherapy on topoisomerase I levels in peripheral blood lymphocytes (PBL).
V. Determine whether TOPO induces apoptosis in PBL from this patient population.
VI. Examine tumor tissue pre- and post-treatment (if available) for topoisomerase I levels, DNA damage, topoisomerase I/DNA complexes, and apoptotic events.
Radiosensitization plus Radiotherapy. Topotecan, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002625
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|