|CANCER & TREATMENTS FOR CANCER CENTER PATIENTS PREVENTION & RISK ASSESSMENT CLINICAL TRIALS & RESEARCH LIVING WITH CANCER|
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Michigan Oncology Journal Fall 1999
Of Interest - Clinical Trials and Clinical Services
Phase I trial using a dendritic cell vaccine for patients with refractory ovarian cancer who have received multiple prior chemotherapy regimens. Using autologous dendritic cells isolated from peripheral blood, a vaccine is prepared using the patient's tumor. The patient receives three vaccinations at two-week intervals. The patient must undergo one pheresis procedure to isolate dendritic cells. The key eligibility criteria for this study include: accessible tumor, typically from malignant ascites or pleural effusion; measurable disease by physical examination or radiographically; normal liver and kidney function; hepatitis and HIV negative; no therapy within the preceding four weeks; and anticipated life expectancy of three months. This therapy has shown promising results in preliminary studies of patients with melanoma and breast cancer. Also, a patient could interrupt salvage chemotherapy, participate in the trial, and then resume additional chemotherapy.
Protocol to evaluate the role of a new MRI contrast agent for liver imaging. Eligible patients are those with liver tumors (primary or metastatic) who are going to have surgical hepatic resection or exploration (wedge resection) cryotherapy, etc. (Non-surgical candidates are not eligible.) Patients undergo a MRI of the liver with the new investigational agent and a CT with a routinely used contrast agent. Imaging tests are separated by 24 hours, and patients undergo blood work. Patients requiring an overnight stay (due to long distance travel) can be accommodated at the Med Inn, and expenses will be covered by the study grant. All expenses for the imaging and interpretation - unless ordered clinically - are covered by the study grant.
Randomized, open-label, controlled multicenter Phase III study in patients with metastatic colorectal cancer. Patients will be randomized to receive standard 5FU/LV with or without SU5416, an angiogenesis inhibitor, to compare median survival. Patients will receive 5FU/LV using the Mayo Clinic regimen and SU5416 will be administered twice weekly IV at a dose of 145mg/m2. Patients will be stratified for known prognostic factors: performance status (ECOG 0 vs. 1); site of primary disease (rectum vs. colon); measurable disease vs. evaluable disease; and prior adjuvant 5-FU (none vs. at least one previous dose). Patients will be assessed every eight weeks (or at time of suspected progression).
The Head and Neck Oncology Program is initiating a new organ preservation protocol for patients with advanced cancers of the oral cavity/oropharynx. This treatment protocol builds on our prior experience with a similar, successful program for squamous cell carcinoma of the larynx. Eligible patients with stage III or stage IV cancers would undergo a single course of induction chemotherapy followed by concomitant chemoradiation followed by adjuvant chemotherapy in order to avoid mutilating surgery. Patients are followed closely to determine quality of life and speech and swallowing outcomes. Correlations of the pre-treatment histology and the expression of genes important in regulating apoptosis are an integral part of this program. It is expected that this treatment will ameliorate the devastating effects of surgery on speech, swallowing and quality of life, without any decrease in cure rates.
The Head and Neck Oncology Program has initiated a new gene therapy program for patients with advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. This program is a Phase II multi-center study incorporating local injections of the gene therapy agent, Allovectin-7. It is an immunotherapeutic approach intended to stimulate an immune response by expressing HLA-b7 antigen within the tumor and potentially restoring some degree of major histocompatibility complex class I tumor antigen presentation. Tumor response, toxicity and the impact of therapy on the quality of life parameters will be determined in this study. Encouraging preliminary results have been obtained in prior studies at a much lower dose of Allovectin-7. Each treatment in the current protocol will include a series of two injections of 100 micrograms, two weeks apart. Patients can undergo a subsequent course of two injections at monthly intervals. Pre-treatment evaluation includes tumor measurements and a CT scan. Follow-up examinations include CT scanning to objectively document tumor regressions.
Abnormal Pap / Colposcopy Clinic