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Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma Clinical research trials and Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma. Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma clinical trial. Participants typically obtain the most effective healthcare available for their Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma  Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
For Condition: invasive malignant thymoma,recurrent malignant thymoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma.
Details: OBJECTIVES: I. Determine the objective response rate in patients with metastatic or recurrent thymoma treated with octreotide. II. Determine the duration of remission in these patients. III. Determine the toxicity of the octreotide regimen in this population. IV. Determine the response rate, duration of remission, survival and toxicity of prednisone added to octreotide in patients with stable disease following octreotide alone. PROTOCOL OUTLINE: All patients receive octreotide subcutaneously three times daily for 1 month. After two courses of treatment, patients are assessed for response. Patients experiencing partial or complete response continue octreotide for a maximum of 1 year (12 courses) in the absence of unacceptable toxicity or disease progression. Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses. These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for the next 3 years, and then annually thereafter. PROJECTED ACCRUAL: There will be 38 patients accrued into this study over approximately 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy - Must have extensive disease defined as: - distant disease - pleural disease with or without mediastinal involvement - recurrent progressive disease in site of previous radiotherapy - Measurable disease with at least one bidimensionally measurable lesion - Must have octreotide scan prestudy that demonstrates activity in the area of measurable disease within 6 months prior to registration --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior chemotherapy allowed if disease progression is demonstrated prior to study entry - Endocrine therapy: Prior or concurrent corticosteroids for myasthenia gravis allowed - Radiotherapy: Prior radiotherapy allowed - Surgery: No postsurgical complications --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine no greater than 3.0 mg/dL - Other: No diabetes mellitus or any other complications to high dose corticosteroid therapy; No acute concurrent complications such as infections; Other prior malignancy(ies) must have been curatively treated and demonstrate no evidence of recurrence; Not pregnant or nursing; Negative pregnancy test; Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidEttinger, Study Chair, Eastern Cooperative Oncology Group
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000066197; E-1C97
Study Start Date: July 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003283
Other Recurrent Malignant Thymoma Studies:
1. Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
Related Studies:
Other recurrent malignant thymoma Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
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