Ewing's Sarcoma Clinical Trial
Official title:
Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement
Verified date | August 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2009 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity Profile | Toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. All toxicities evaluated according to NCI Common Toxicity Criteria, Version 3.0 and recorded prior to each cycle of therapy. | From baseline to end study period (3 years) | Yes |
Secondary | Number of Participants with Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Response by tumor measurements (centimeters) using RECIST criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or > new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. | Baseline till after three cycles of therapy (approximately 9 weeks) | No |
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