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Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Clinical research trials and Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung. Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung clinical trial. Test subjects typically receive the most expert healthcare available for their Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung  Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
For Condition: lung metastases,Recurrent Melanoma,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: Phase I trial to study the effectiveness of inhaled sargramostim in treating patients who have melanoma that is metastatic to the lung.
Details: OBJECTIVES: - Determine immunomodulatory effects of aerosolized sargramostim (GM-CSF) in patients with metastatic melanoma to the lung. - Determine toxicity profile, in terms of pulmonary and hematologic toxicity, of this therapy in these patients. - Determine, preliminarily, the therapeutic effects of this therapy, in terms of progression-free survival, overall survival, and objective response rate, in these patients. OUTLINE: This is a dose-escalation study. Patients receive aerosolized sargramostim (GM-CSF) twice a day on days 1-7 and 15-21. Treatment repeats every 28 days for 2 courses. Patients with no disease progression after completion of course 2 may continue on treatment for up to 2 years. Cohorts of 5-10 patients receive escalating doses of GM-CSF until the optimal immunostimulatory dose (ISD) is determined. The optimal ISD is defined as the dose at which at least 7 of 10 patients experience immunostimulation. Once the optimal ISD is determined, 10 patients receive aerosolized GM-CSF at a dose halfway between the optimal ISD and the preceding dose. Dose escalation is discontinued if at least 2 of 5 or at least 4 of 10 patients on a particular dose level experience dose-limiting toxicity. Patients are followed at 3 months, every 2 months for 1 year, and then every 4 months for 2 years. PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma to the lung for which no known standard therapy exists - At least 1 unidimensionally measurable lesion - HLA-A2 positive - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8.0 g/dL Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: - Creatinine no greater than 2.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Pulmonary: - No pulmonary disease requiring concurrent active therapy (e.g., supplemental oxygen or bronchodilator) - FEV_1 at least 65% of predicted and at least 1.5 L Immunologic: - No known immunodeficiency state - No known autoimmune disease - No uncontrolled infection Other: - No active psychotic disorder requiring pharmacotherapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 2 weeks since prior biologic therapy - More than 2 weeks since prior immunotherapy - More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - No other concurrent biologic therapy or immunotherapy - No concurrent G-CSF - No concurrent GM-CSF other than study drug Chemotherapy: - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy Endocrine therapy: - More than 2 weeks since prior corticosteroids - No concurrent glucocorticosteroids Radiotherapy: - More than 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - More than 7 days since prior parenteral antibiotics - No concurrent parenteral antibiotics - No concurrent immunosuppressive agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SvetomirMarkovic, Study Chair, Mayo Clinic Cancer Center
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital *Recruiting*
Minneapolis, Minnesota, 55407
United States
Recruiting Daniel Schneider 612-863-5654
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Svetomir Markovic 507-284-2511
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Additional Information:
Study ID Numbers: CDR0000068654; NCCTG-N0071
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017121
Other Stage 4 Melanoma Studies:
1. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
2. Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
3. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
4. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
5. CCI-779 in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Florida Clinical Trials
Other Jacksonville Clinical Trials
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
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