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.

Condition	Treatment or Intervention	Phase
recurrent malignant thymoma invasive malignant thymoma	Drug: octreotide  Drug: prednisone	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

California
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
Florida
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States
      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611,  United States
Indiana
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231,  United States
Massachusetts
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
      Veterans Affairs Medical Center - Albany, Albany,  New York,  12208,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Nashville, Nashville,  Tennessee,  37212,  United States
South Africa
      Pretoria Academic Hospitals, Pretoria,  0001,  South Africa

Study chairs or principal investigators

David S. Ettinger,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000066197; E-1C97
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08