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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer  Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 3 renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest 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 study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol. II. Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug. III. Determine the qualitative and quantitative toxic effects of this drug in this patient population. IV. Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer - At least 1 unidimensionally measurable lesion; At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan; Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable; Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field - No prior or concurrent brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed; At least 28 days since prior immunotherapy and recovered; No concurrent prophylactic filgrastim (G-CSF) - Chemotherapy: No prior chemotherapy for renal cell cancer - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 21 days since prior radiotherapy and recovered - Surgery: See Disease Characteristics; Prior resection of primary tumor allowed; At least 28 days since prior surgery and recovered --Patient Characteristics-- - Age: Not specified - Performance status: Zubrod 0-2 - Life expectancy: Not specified - Hematopoietic: No hypercoagulable state other than renal cell cancer - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No symptomatic congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia; No prior isolated occurrence of deep venous thrombosis within the past 6 months - Pulmonary: No prior isolated occurrence of pulmonary embolism within the past 6 months - Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission; No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I); No other uncontrolled illness (e.g., diabetes mellitus); No ongoing or active infection; No psychiatric illness or social situation that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterVanVeldhuizen, Study Chair, Southwest Oncology Group
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79415
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Additional Information:
Study ID Numbers: CDR0000068634; SWOG-S0109
Study Start Date: May 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016939
Other Stage 4 Renal Cell Cancer Studies:
1. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
2. Vaccine Therapy in Treating Patients With Kidney Cancer
3. Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
4. Interferon alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
5. Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
Related Studies:
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Other South Carolina Clinical Trials
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Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
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