MDACC Study Summary 2007-0738

Study Summary
No. 2007-0738:.......Kidney......Christopher Wood......Urology

Study Summary Title



Study Summary Number:	2007-0738

Study Title:	International Survival Follow- up Registry of Patients Previously Enrolled in the Renal Cell Carcinoma Evaluation of Adjuvant Oncophage® Treatment in the Antigenics C-100-12 (Part 1) Protocol. (INSPIRE Registry)

Physician

New Patient Referral



Name:	Christopher Wood	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring 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

General Information



Disease Group:	Kidney	Supported By:	Antigenics, Inc

Phase of Study:	N/A	Return Visit:	Patients may return for routine follow-up, and we would consent them at that time. There is no specified return visits for this protocol, but if patients continue to be followed by a MDACC physician, we will obtain follow-up information.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	No hospitalization will be required

Description/
Intervention:

The goal of this study is to collect long-term follow-up information on
patients who took part in the study called "A Multi-Center, Randomized Phase
III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk
of Recurrence After Surgical Treatment for Renal Cell Carcinoma".

In that study, some participants received a drug called Oncophage® (HSPPC-96)
and other participants did not receive it.

This registry study is also designed to create a database of medical
information about patients with kidney cancer who took part in the earlier
study, in order for researchers to track and review any long-term health
differences between patients who did and did not receive HSPPC-96.

Study Objectives / Outcomes

The primary objective of the INSPIRE Registry protocol C-100-27 is to evaluate overall survival for patients previously enrolled as study patients in the Antigenics C-100-12 (Part 1) protocol.

A secondary objective of this registry is to describe investigator-reported disease recurrence for patients who, at time of the study closure, were reported by the investigator as being disease-free.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	06/04/2008

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	530

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) Participated as an eligible patient in the Antigenics C-100-12 (Part 1) protocol, with last survival status reported as "alive" and reason off-study reported as "administrative study closure"

2) Signed an informed consent to participate in the INSPIRE Registry, and be willing to receive contact from a representative from the protocol investigative study centers and/or any subsequently identified co-investigator sites or US lead investigator at MDACC, and/or a registry team member from the contract research organization (CRO) every 6 months if no disease recurrence and every 3 months if disease has recurred

Exclusion Criteria:

1) No Exclusion Criteria Noted

Links

Registration Number: NCT00033904
Study Information on Clinical Trials Registry (clinicaltrials.gov)