Local lead investigator, Fruehauf , J

This is the first large international study of ADJUVANT CHEMOHORMONE Rx in CaP patients at high-risk for relapse after radical prostatectomy. Subjects are randomized between 30-90d after operation to one of two arms: immediate adjuvant treatment, or observation.

In the latter situation, subjects then get adjuvant treatment is the PSA increases to 0.4ng/mL. Treatment is also randomized in each of these situations: 18mos of androgen ablation (Eligard) vs 18mos of androgen ablation plus several cycles of Taxotere Q 3wks. Endpoint is biochemical or clinical relapse/progression.

Major inclusion criteria include (but are not limited to):

1. Relapse risk of at least 40% by Kattan post-operative nomogram (realistically this means Gleason 7 or more, high pre-op PSA, and some combination of positive LNs, seminal vesicals, or extracapsular extension).
2. Undetectable PSA at least 30d post-operation.
3. Must be randomized and start Rx before 90d post-operation
4. No prior chemotherapy, hormone Rx, or radiation

A Phase III Randomized Open-label Study of CG1940 and CG8711 vs Docetaxel and Prednisone in Patients with Metastatic Hormone-refractory Prostate Cancer Who are Chemotherapy-naïve. (= VITAL 1 Study)

Local lead investigator, Fruehauf, J

This is a randomized study comparing an allogeneic cell-based vaccine with standard chemotherapy in patients with HRPC and ASYMPTOMATIC metastatic disease. The vaccine consists of irradiated, standard prostate cancer cell lines (LNCaP and PC3) that have been transduced with the GM-CSF gene. The vaccine is given subcutaneously every 2-4 weeks for up to 10 months. The chemotherapy is standard docetaxel and prednisone Q 3wks for up to 9 cycles. Endpoint is biochemical or clinical relapse/progression.

Major inclusion criteria include (but are not limited to):

1. Detectable metastases by bone scan, CT, or MRI. Subjects cannot have elevated PSA only.
2. No prior chemotherapy or vaccines.
3. Progressive disease with castrate levels of testosterone.
4. No cancer-related pain that requires any opiod (NSAIDs OK)

1. Resected RCC of any histologic type.
2. Subjects must have had the primary tumor >4cm (≥T1b), or resected renal vein or IVC thrombus, or resected macroscopic LNs.
3. No significant cardiac disease, recent thrombotic or vascular events
4. No distant metastases
5. Must be randomized and start treatment between 4-12 weeks after surgery

Phase II Evaluation of oxaliplatin and gemcitabine in patients with metastatic bladder cancer

Local lead investigator, Fruehauf, J

A chemotherapy study for subjects with metastatic or locally recurrent bladder cancer and no more than 1 prior chemotherapy regimen. Treatment continues until disease progression or unacceptable toxicity

Major inclusion criteria include (but are not limited to):

1. No prior gemcitabine or oxaliplatin
2. Locally recurrent disease must be incurable by radiation or surgery
3. Measurable metastatic or local disease by radiographic studies.