Trial of G250 Peptide and IL-2 Following Surgical Resection of Locally Advanced/Metastatic Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the experimental vaccine G250 with or without IL-2 can produce an immune response in patients with renal cell carcinoma who have had all their cancer removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago

Criteria

Inclusion Criteria:

• Patients must express HLA-A2

• Patients must have histologically or cytologically proven renal cell carcinoma that expresses G250 by IHC

• Patients must have completely resected disease without any evidence of residual local or metastatic disease

• Patients with resected locally advanced disease

• Patients with metastatic disease(including synchronous metastatic site)

• Patients with solitary metachronous metastatic disease

• Age >/=18 years

• ECOG performance status 0-1

• Patients must have normal organ and marrow function

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have had chemotherapy, radiotherapy, or an experimental (investigational) agent prior to starting treatment. Prior biologic therapy (IL-2 or interferon) is allowed only if it precedes a curative surgical therapy.

• Patients may not have received a previous G250 vaccine.

• Patients with residual metastatic disease following surgical resection are excluded from this clinical trial.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to G250, Montanide ISA-5 1, OM-CSF, or IL-2.

• Patients must not have autoimmune disorders (SLE, Rheumatoid Arthritis), conditions of immunosuppression (such as HIV), or treatment with immunosuppressive drugs (including oral steroids, continuous use of topical steroids, steroid inhalers). Replacement doses of steroids for patients with adrenal insufficiency are allowed.

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active GI bleeding, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant or breast-feeding women

• HIV-positive patients

• Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered.