Completed

NCT Number: NCT00002625

Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma

Phase I trial to study the effectiveness of topotecan and radiation therapy in treating patients who have solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells.

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Key information

Conditions

Esophageal Cancer Bronchial Neoplasms Burkitt Lymphoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chronic Disease DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Epstein-Barr Virus Infections Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan Hydrochloride

Drug

low-LET electron therapy

Radiation

low-LET photon therapy

Radiation

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION

Important dates

Study start: 1995
Primary completion: 2000
Study completion: 2000
First posted: Jun 10, 2004
Registry last updated: Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed