PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
18 Years
N/A
Both
Esophageal Cancer, Lung Cancer, Lymphoma
Trial Information
PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
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).
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
George Wilding, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000063990
NCT ID:
NCT00002625
Start Date:
March 1995
Completion Date:
September 2000
Related Keywords:
- Esophageal Cancer
- Lung Cancer
- Lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- recurrent non-small cell lung cancer
- recurrent adult Hodgkin lymphoma
- recurrent esophageal cancer
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent small cell lung cancer
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Esophageal Diseases
- Esophageal Neoplasms
- Lung Neoplasms
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
