PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
topotecan hydrochloride
+ low-LET electron therapy
+ low-LET photon therapy
Bronchial Neoplasms+50
+ Carcinoma, Bronchogenic
+ Chronic Disease
Treatment Study
Summary
Study start date: March 1, 1995
Actual date on which the first participant was enrolled.OBJECTIVES: 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. OUTLINE: 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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 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.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Microscopically confirmed solid tumor or lymphoma not potentially curable by conventional surgery or radiotherapy Previously unirradiated disease scheduled to receive thoracic irradiation of up to 60 Gy, including pulmonary and esophageal tumors No metastatic disease more effectively treated by systemic chemotherapy No history of brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 WBC at least 4,000 ANC at least 1,500 Platelets at least 100,000 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 1.5 mg/dL Calcium no greater than 11.0 mg/dL No pregnant or nursing women Pregnancy test required, as appropriate Effective contraception required of fertile patient PRIOR CONCURRENT THERAPY: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered At least 4 weeks since radiotherapy and recovered
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
University of Wisconsin Comprehensive Cancer Center
Madison, United StatesOpen University of Wisconsin Comprehensive Cancer Center in Google Maps