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Study Summary
No. ID02-466:.......Kidney......Christopher Wood......Urology
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Study Summary Title
Study Summary
Number:		ID02-466
Study Title:A Randomized Phase II Study Investigating the Route of Administration of Oncophage® (HSPPC-96) in Patients with Metastatic 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:		Five weeks after surgery, patients return once a week for four weeks, then
every other week for vaccine until supply is depleted or evidence of tumor
progression shows. Tumor surveillance patients will follow-up every three
months the first year.
Treatment
Agents:		HSPPC-96Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients will be hospitalized for cytoreductive nephrectomy. The tumor from
the nephrectomy specimen will be used for vaccine preparation. Typical
hospital stays for this procedure: 7-10 days.
Description/
Intervention:		The goal of this clinical research study is to compare the effectiveness of a
new vaccine, HSPPC-96, in the treatment of metastatic kidney cancer, when the
vaccine is given in different ways. Researchers will compare the effectiveness
of the vaccine when given subcutaneously (underneath the skin) or intradermally
(into the skin). The safety of treatment with HSPCC-96 will also be studied.
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Study Objectives / Outcomes
Primary objective:
Determine whether intradermal or subcutaneous administration of HSPPC-96 leads to a higher response proportion.

Secondary objective:
Assess frequency of adverse events in subjects receiving HSPPC-96 at the above routes. Determine survival.
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Study Status Information
Study Activation / Registration Date:07/25/2003
IRB Review and Approval Date:06/18/2003
Study Type:Therapeutic
Recruitment Status:Closed
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) Pre-surgery -Metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor

2) Pre-surgery -No previous therapy for metastatic renal cell carcinoma

3) Pre-surgery - Measurable disease (RECIST Criteria)

4) Pre-surgery - Primary tumor >/= 7 cm on CT or MR

5) Pre-surgery - ECOG performance score 0-1

6) Pre-surgery - Life expectancy >/= 3 months

7) Pre-surgery - Planned nephrectomy

8) Pre-surgery - Adequate cardiac function (NYHA I-II)

9) Pre-surgery - Signed written informed consent according to ICH-GCP and the investigational site rules

10) Pre-surgery - Age >/= 18.

11) Pre-surgery - Absence of multiple liver metastases, brain, or threatening bone metastases (axial skeleton and/or pathological fractures) or bone metastases only documented by: (a) Abdomen/pelvis CT or MRI (b) Chest CT or MRI (c) Brain CT or MRI (d) Nuclear bone scan

12) Pre-surgery - Negative urine or serum pregnancy test for women of childbearing potential

13) Post-surgery - Metastatic renal cell carcinoma (AJCC Stage IV)

14) Post-surgery - Conventional renal cell carcinoma histology with estimated < 25% sarcomatoid features

15) Post-surgery - Provide Antigenics with at least eleven grams of viable tumor tissue for vaccine production

16) Post-surgery - ECOG performance score 0-1

17) Post-surgery - Adequate bone marrow function (ANC ³ 1.5 x 109/L; platelets ³ 100 x 109/L.)

18) Post-surgery - Adequate cardiac function (NYHA I-II)

19) Post-surgery - Adequate renal and hepatic function: (a) Creatinine £ 2.3 mg/dL </= 2x ULN, (b) Total Bilirubin £ 1.5 mg/dL </= 2x ULN, (c) ALT £ 2.5 x the upper limit of normal in absence of liver metastasis or </= 5 x the upper limit of normal in presence of liver metastasis, (d) Women of child producing potential must agree to use contraception during the study
Exclusion Criteria:1) Pre-surgery - History of primary or secondary immunodeficiency, or subjects using systemic corticosteroids or cyclosporin A

2) Pre-surgery - Other cancer (including renal cell carcinoma) within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

3) Pre-surgery - Embolization of the renal artery prior to nephrectomy

4) Pre-surgery - Active, uncontrolled infection or other serious medical illnesses

5) Post-surgery - Current malignancies at other sites

6) Post-surgery - Active, uncontrolled infection or other serious illnesses.

7) Post-surgery - Participation in any other studies requiring administration of an investigational drug/biologic agent starting 4 weeks prior to treatment
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Links
Registration Number: NCT00082459
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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