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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002625

Collaborator

(none)

Enrollment

Location

Arm

66.1

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Lung Cancer Lymphoma	Drug: topotecan hydrochloride Radiation: low-LET electron therapy Radiation: low-LET photon therapy	Phase 1

Detailed Description

OBJECTIVES:

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.
Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment.
Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels.
Evaluate, using Western blot and immunohistochemical stain, the effects of TOPO/radiotherapy on topoisomerase I levels in peripheral blood lymphocytes (PBL).
Determine whether TOPO induces apoptosis in PBL from this patient population.
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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION

Study Start Date :

Mar 1, 1995

Actual Primary Completion Date :

Apr 1, 2000

Actual Study Completion Date :

Sep 1, 2000

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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