Aerosol L9-NC and Temozolomide in Ewing's Sarcoma

Completed · Phase 1/Phase 2

Conditions studied: Ewing's Sarcoma

In brief

Primary Objectives: 1. To determine the feasibility and toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. 2. To determine the effectiveness of L9-NC given by aerosol in combination with temozolomide in patients with solid tumors involving the lungs.

Key facts

Study ID

NCT00492141

Run by

M.D. Anderson Cancer Center

People needed

10

Starts

2006-06-01

Expected to finish

2009-09-01

Last updated by the study team

2012-08-02

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients, 10 years of age or older, with primary or metastatic cancer in the lungs, who have failed or progressed on front line therapy and have no standard therapies available for treatment are eligible. Patients may also have disease in other sites, but must have current lung involvement to be eligible.
• Patients should have adequate bone marrow function, defined by: absolute peripheral granulocyte count of >/= 1500 cells/mm\^3, platelet count > 100,000 platelets/mm\^3, and Hgb > 8.0 g/dl. For patients with documented bone marrow involvement, the following counts are acceptable for enrollment: absolute peripheral granulocyte count of > 1000 cells/mm\^3 , platelet count > 75,000 platelets/mm\^3.
• Patients should have adequate hepatic function, defined by: total bilirubin < 2 mg/dl and ALT or AST < 2x upper limit of normal.
• Patients should have adequate renal function, defined by serum creatinine </= 2 mg/dl.
• Patients must have adequate pulmonary function, as defined by a pulmonary function test with: >/= 50% FVC, >/= 50% FEV1 and >/= 50% DLCO of predicted values

You may not qualify if…

• Patients with symptomatic brain metastases.
• Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
• Patients receiving concurrent chemotherapy.
• Patients may not receive concurrent radiation therapy to the chest during cycles 1-3. Radiation therapy to disease in other areas of the body is permissible at any time, but such lesions will not be evaluable for response. Although patients who have received prior radiation to the chest are eligible, patients should be at least 4 weeks from prior radiation to the chest. Any chest lesion treated with radiation must have progressed to be considered measurable for this study.
• Patients with severe medical problems such as uncontrolled diabetes mellitus (glucose consistently greater than 200 mg/dl, or Hemoglobin A1c greater than 8%) or symptomatic cardiovascular disease (New York class III) or active infections requiring IV antibiotics are not eligible for this trial.
• Patients requiring oxygen.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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