Non Hodgkin Lymphoma Clinical Trial

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

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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.

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Full 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).

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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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT00002625

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT00002625

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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