Aerosol L9-NC and Temozolomide in Ewing's Sarcoma - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00492141

Purpose

Primary Objectives:

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	Intervention	Phase
Ewing's Sarcoma	Drug: Temozolomide Drug: L9-NC	Phase I Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Temozolomide Camptothecin Rubitecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if liposomal 9-nitro-20(S)-camptothecin (L9-NC) given alone and given in combination with Temodar (temozolomide) can help to control Ewing's sarcoma or another type of cancer that has spread to the lungs. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The safety and effectiveness of L9-NC alone and given in combination with temozolomide will also be studied. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental L9-NC + Temozolomide	Drug: Temozolomide Cycle 2, Dose Level 1 = 100 mg/m^2 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 approx. 30 minutes per day will be 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, approx. 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given BID, 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.

Arms

Assigned Interventions

1: Experimental

L9-NC + Temozolomide

Drug: Temozolomide

Cycle 2, Dose Level 1 = 100 mg/m^2 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 approx. 30 minutes per day will be 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, approx. 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given BID, 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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492141

Contacts

Contact: Cynthia E. Herzog, MD

713-792-6620

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Cynthia E. Herzog, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Cynthia E. Herzog, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Cynthia E. Herzog, MD/Associate Professor )
Study ID Numbers:	2005-0889
Study First Received:	June 26, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00492141
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Ewing's Sarcoma
Lung Involvement
Temozolomide
Temodar

Aerosol Liposomal 9-Nitro-20(S)-Camptothecin
Aerosol L9-NC
L9-NC

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Ewing's family of tumors
Malignant mesenchymal tumor
Sarcoma

Osteosarcoma
9-nitrocamptothecin
Temozolomide
Osteogenic sarcoma
Camptothecin
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Alkylating Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009