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

February 8, 2013 updated by: National Cancer Institute (NCI)

PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Primary Completion (Actual)

April 1, 2000

Study Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 9, 2004

First Posted (Estimate)

June 10, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000063990 (Registry Identifier: PDQ (Physician Data Query))
  • WCCC-CO-9492
  • NCI-T94-0099C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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