Clinical trial NCT00002625: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: George Wilding, MD
role: STUDY_CHAIR
References:
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.