Aerosol L9-NC and Temozolomide in Ewing's Sarcoma
|ClinicalTrials.gov Identifier: NCT00492141|
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : August 2, 2012
- 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.
- To determine the effectiveness of L9-NC given by aerosol in combination with temozolomide in patients with solid tumors involving the lungs.
|Condition or disease||Intervention/treatment||Phase|
|Ewing's Sarcoma||Drug: Temozolomide Drug: L9-NC||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||September 2009|
Experimental: L9-NC + Temozolomide
Liposomal 9-nitro-20(S)-camptothecin (L9-NC) alone, total 10 ml of 0.4 mg/ml in aerosol reservoir once a day for 5 days in row each 2 weeks, followed by 2 weeks off; then in combination with Temozolomide 100 mg/m^2 oral/day for Cycle 2 Days 1-5.
Cycle 2, Dose Level 1 = 100 mg/m^2 by mouth (PO) Daily, Days 1-5 Prior to L9-NC; Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, advance to 100 mg/m^2 PO Every 12 Hours, Days 1-5 Prior to L9-NC. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2; Cycle 4 and beyond = Patients will continue on dose level 1 or 2 as given in cycle 3.
Other Name: TemodarDrug: L9-NC
Cycle 1 = Administered by aerosol 5 consecutive days per week for 2 weeks. A total of 10 ml of 0.4 mg/ml in an aerosol reservoir delivered over approximately 30 minutes per day given once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
Cycle 2, Dose Level 1 = Week 1, doses 1-5 preceded by temozolomide. Continue L9-NC once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, due to drug, during cycle 2, L9-NC may be increased to twice daily, approximately 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given twice a day, 5 days a week, for 2 weeks, followed by 2 weeks off. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2.
Cycle 4 and beyond, patients will continue on dose level 1 or 2 as given in cycle 3.
- Toxicity Profile [ Time Frame: From baseline to end study period (3 years) ]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.
- Number of Participants with Response According to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Baseline till after three cycles of therapy (approximately 9 weeks) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492141
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Cynthia E. Herzog, MD||M.D. Anderson Cancer Center|