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


Phase 1/Phase 2
10 Years
N/A
Not Enrolling
Both
Ewing's Sarcoma

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Trial Information

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


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 further cycles of treatment, if you experienced any bad side effects during Cycle 3,
you will receive L9-NC only once a day, instead of twice a day. If you are already
receiving L9-NC only once a day, and you experience intolerable side effects in Cycle 3, you
will be taken off this study.

You will be shown how to do spirometry (a lung test that measures how much and how fast air
moves out of the lungs) to monitor the safety of your therapy. You will be asked to do this
after each treatment cycle, for the first 2 cycles. If your dose of L9-NC is increased to
twice a day, you will also be asked to do spirometry after the second dose of the day during
Cycle 3. For future cycles, you will be asked to do spirometry after the last dose of
L9-NC, on the first day of each week of treatment. The results of spirometry will need to
be sent to M.D. Anderson by telephone, after each test. The results will be sent
electronically. They will be reviewed every day after they are received, and you will be
contacted if there are abnormal results. Your doctor may also perform additional spirometry
as needed.

You will be examined by a doctor before the second and third cycle of therapy (every 4
weeks). You will have blood drawn (about 2 tablespoons) every week during the first 2 to 3
cycles of therapy. After Cycle 3 of therapy, blood tests (about 2 tablespoons) will be done
before each cycle of therapy. Chest x-rays, CT chest scans, and any other imaging studies,
as done at the beginning of this study, will be done to measure your disease and will be
repeated after every 3 cycles of therapy. You will also have a breathing function test, if
the doctor thinks it is necessary.

If your tumor size decreases during this treatment, you may have other therapy performed,
such as surgery, radiation, or radiofrequency ablation, outside of this study. If the
treatment in this study alone, or in combination with other therapy, results in complete
disappearance of your disease, your treatment on this study may continue for up to 6 more
cycles.

You will be taken off this study if your disease gets worse or you experience any
intolerable side effects. If you are taken off this study for intolerable side effects, you
will be followed-up for 30 days after treatment ends or until your side effects go away.

If you have a complete remission, chest x-rays, CT chest scans, and any other imaging
studies, as done at the beginning of this study, will be done to look for disease about
every 3 months after completion of treatment.

This is an investigational study. L9-NC is authorized by the FDA for use in research only.
Temozolomide is approved by the FDA. The use of these drugs together in this study is
experimental. Up to 40 patients will take part in this study. All will be enrolled at M.D.
Anderson.


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 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity Profile

Outcome Description:

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.

Outcome Time Frame:

From baseline to end study period (3 years)

Safety Issue:

Yes

Principal Investigator

Cynthia E. Herzog, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2005-0889

NCT ID:

NCT00492141

Start Date:

June 2006

Completion Date:

September 2009

Related Keywords:

  • Ewing's Sarcoma
  • Ewing's Sarcoma
  • Lung Involvement
  • Temozolomide
  • Temodar
  • Aerosol Liposomal 9-Nitro-20(S)-Camptothecin
  • Aerosol L9-NC
  • L9-NC
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030