Genitope Protocol 2002-09

A Phase 2 Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituxan®, in Previously Treated Patients with Follicular Non-Hodgkin's Lymphoma (Protocol: G2002-09)

Status: Closed to patient registration.

Design: Study 2002-09 is a Phase 2, open label study evaluating patients registered on Genitope study 2000-03 who fail CVP chemotherapy or progress during the 6 month rest period following chemotherapy specified in the protocol. Eligible patients then receive treatment with the anti-CD20 antibody, Rituxan® (Rituximab), followed by a series of immunizations with specific immunotherapy containing a patient-specific idiotype (Id) conjugated to KLH, recombinant Id-KLH. Patients in this study will receive four doses of Rituxan® followed by immunizations of Id-KLH with GM-CSF.

Primary Objectives:

1) To evaluate time to tumor progression from start of salvage treatment with Rituxan®, followed by immunizations with Id-KLH and GM-CSF in patients with follicular NHL in first relapse

2) To evaluate immune response among patients with follicular NHL in first relapse following immunization with Id-KLH and GM-CSF administered following salvage treatment with Rituxan®.

3) To evaluate safety and toxicity of immunizations with Id-KLH and GM-CSF administered following salvage treatment with Rituxan®.

Selected Eligibility Criteria:

Major Screening Criteria: Patients must have been previously registered in Genitope study 2000-03, completed all eight cycles of CVP chemotherapy per Genitope study 2000-03 protocol, and have failed to achieve at least a partial response to chemotherapy or have documented progressive disease during the 26 week rest period in Genitope study 2000-03.

Eligibility for Immunization:

1) Patients must have received four 375mg/M2 doses of Rituxan® and all pre- and post-Rituxan® assessments.

2) Patients must have achieved a partial response or better to Rituxan® and have not met progressive disease criteria during the interval between Rituxan® and the start of immunizations with Id-KLH and GM-CSF.

3) Patients who have received more or less than four doses of Rituxan® are ineligible.

4) Patients may only receive Rituxan for the treatment of lymphoma since the failure to achieve partial response after eight cycles of CVP chemotherapy or the progression of disease during the mandatory rest period in study 2000-03, with the exception of treatment of no more than two sites with radiation.

Treatment: Following four doses of Rituxan® and a rest period, eligible patients will receive a series of eight immunization series over about 12 weeks. Each immunization series consists of subcutaneous injections of Id-KLH and GM-CSF administered over four days at two-week intervals. On day one of each immunization series, patients receive the Id-KLH as a divided dose administered at two separate injection sites, immediately followed by injection of GM-CSF (250µg total dose divided equally between the two injection sites). Patients then receive GM-CSF (250 µg total dose divided equally between the two injection sites) on days two, three and four of each immunization series.

Sponsor: Genitope Corporation, 6900 Dumbarton Cr., Fremont, CA  94555-3651, 1-866-Genitop (1-866-436-4867).