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

Primary Purpose

Esophageal Cancer, Lung Cancer, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
topotecan hydrochloride
low-LET electron therapy
low-LET photon therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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).

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002625
Brief Title
Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma
Official Title
PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
September 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Lung Cancer, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
low-LET electron therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET photon therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wilding, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15013589
Citation
Forouzannia A, Schiller J, Berlin J, Hutson P, Boothman D, Storer B, Wilding G, Mehta M. A phase I study of Topotecan, as a radiosensitizer, for thoracic malignancies. Lung Cancer. 2004 Apr;44(1):111-9. doi: 10.1016/j.lungcan.2003.10.005.
Results Reference
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Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma

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