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Study Summary
No. ID01-205:.......Kidney......Christopher Wood......Urology
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Study Summary Title
Study Summary
Number:		ID01-205
Study Title:A Randomized Phase II Trial Studying Adjuvant Thalidomide For Patients At High Risk Of Disease Recurrence Following Surgery For Renal Cell Carcinoma
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Physician New Patient Referral
Name:Christopher WoodPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3250
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Following enrollment in the protocol and randomization, patients will be
followed with a clinical evaluation every 3 months for two years, then every 6
months for three years, then yearly after that.
Treatment
Agents:		ThalidomideHome Care:Patients will take their thalidomide therapy at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Thalidomide therapy will be given on an outpatient basis. No hospitalization
required.
Description/
Intervention:
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Study Objectives / Outcomes
Primary Objectives
    1.1 To determine if adjuvant thalidomide can decrease the recurrence rate in patients with renal cell carcinoma that are rendered surgically without evidence of disease and are at high risk for disease recurrence.

    Secondary Objectives
      1.2 To determine the impact of adjuvant thalidomide on serum and urine levels of angiogenesis factors, growth factors, and immunomodulatory cytokines (bFGF, VEGF, IL-8, IL-10).

      1.3 To determine the impact of adjuvant thalidomide therapy on the quality of life of patients with renal cell carcinoma.
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      Study Status Information
      Study Activation / Registration Date:11/01/2001
      IRB Review and Approval Date:09/19/2001
      Study Type:Therapeutic
      Recruitment Status:Terminated
      Projected Accrual:N/A
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      Enrollment Eligibility
      If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
      Inclusion Criteria:1) All patients must have undergone a radical nephrectomy for renal cell carcinoma and be surgically and/or radiographically without evidence of local or metastatic disease within 2 months of the time of study enrollment. Management of the adrenal gland and the retroperitoneal lymph nodes at the time of surgery is left to the discretion of the operating surgeon. The surgical specimen must be reviewed by our designated study pathologist to confirm pathologic stage, grade, and margin status.

      2) The following classifications of disease, following complete surgical resection, are eligible for enrollment: a) Clinically localized: T2 (Fuhrman's grade 3 and 4), T3a, T3b, T3c, T4 (N0, M0), b) Margin positive: Tany, N0, M0, Margin + c) Nodal metastases that are completely resected: Tany, N1-2, M0, d) Bilateral renal cell carcinoma

      3) Perfomance status of less than or equal to 3 (Zubrod Scale, Appendix C)

      4) Adequate bone marrow function is defined as an absolute neutrophil count greather than or equal to 1500 mm(3) and platelet count greater than or equal to 100,000 mm(3); adequate hepatic function with a bilirubin less than or equal to 1.5 mg% and SGPT < 4X the upper limit of normal; and adequate renal function with a creatinine less than or equal to 2.0 mg%

      5) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, keeping with the policies of this hospital. The only approved consent form is appended to this protocol.

      6) Women must not be pregnant or lactating. Patients of childbearing potential are eligible providing they practice adequate contraception.
      Exclusion Criteria:1) Measurable residual or metastatic disease at study enrollment

      2) History of other, noncutaneous malignancy within the last 5 years

      3) Previous exposure to adjuvant or neoadjuvant therapy for renal cell carcinoma (immunotherapy, radiation therapy, chemotherapy).

      4) Women of child bearing potential must have a negative pregnancy test at the time of enrollment

      5) Previous exposure to thalidomide

      6) Patients with a history of seizure disorder being treated with barbiturates. These patients may become eligible if they are changed over to a different form of anticonvulsant therapy
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      Links
      Registration Number: Not Registered
      Other Links:
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      Results

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