Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Lung Cancer Lymphoma |
Drug: topotecan hydrochloride Radiation: low-LET electron therapy Radiation: low-LET photon therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION |
| Enrollment: | 5 |
| Study Start Date: | March 1995 |
| Study Completion Date: | September 2000 |
| Primary Completion Date: | April 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002625 History of Changes |
| Other Study ID Numbers: | CDR0000063990, WCCC-CO-9492, NCI-T94-0099C, CDR0000063990 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013