Clinical Trial: Aerosol L9-NC and Temozolomide in Ewing's Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement

Brief Summary:

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.

Detailed Summary:

L9-NC and temozolomide each work by blocking certain tumor cell functions, which can keep tumor cells from growing.

If you are found to be eligible to take part in this study, you will be given the L9-NC aerosol (an inhaled spray) by mouth through a face mask for Cycle 1 of therapy. You will receive L9-NC over about 30 minutes once a day, for 5 days in a row. This will be done for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment. A treatment cycle lasts for 4 weeks.

Your first L9-NC aerosol treatment, during Cycle 1, will be given at M.D. Anderson. You may receive the rest of your treatments at home, if you experienced no bad side effects with the first aerosol treatment.

During Cycle 2 of therapy, if you have not experienced any intolerable side effects, you will be given temozolomide. You will receive temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will also continue to receive the L9-NC aerosol over about 30 minutes once a day, for 5 days in a row, for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment.

During Cycle 3 of therapy, if you have not experienced any intolerable side effects, you will continue to be given temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will receive the L9-NC aerosol twice a day, about 12 hours apart, over about 30 minutes, for 5 days in a row, for 2 weeks. If you experience any bad side effects during Cycle 2, your dose of temozolomide will be decreased, and you will continue to receive L9-NC aerosol once a day (instead of twice a day), for 5 days in a row, for 2 weeks.

For all fu
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome: 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.


Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: June 26, 2007
Date Started: June 2006
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012