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Aerosol L9-NC and Temozolomide in Ewing's Sarcoma

NCT00492141 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-08-02

No results posted yet for this study

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.

Conditions

  • Ewing's Sarcoma

Interventions

DRUG

Temozolomide

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.

DRUG

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Cynthia E. Herzog, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-05-31
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00492141 on ClinicalTrials.gov