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

NCT ID: NCT00002625

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-03-31
• Study Completion Date: 2000-09-30

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).

Conditions

Esophageal Cancer; Lung Cancer; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

topotecan hydrochloride

Intervention Type: DRUG

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Interventions

topotecan hydrochloride

Intervention Type: DRUG

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Wilding, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 15013589 (View on PubMed)

Other Identifiers

WCCC-CO-9492

Identifier Type: -

Identifier Source: secondary_id

NCI-T94-0099C

Identifier Type: -

Identifier Source: secondary_id

CDR0000063990

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000063990

Identifier Type: -

Identifier Source: org_study_id