OVERVIEW:

The Multidisciplinary Phase I Clinical –Pharmacology Team at the Barbara Ann Karmanos Cancer Institute (KCI) provides patients with advanced, refractory, cancer the opportunity to undergo experimental treatment with promising novel anticancer agents. This unique program, investigate the testing of new agents by themselves or combined with more standard treatments based on promising experimental laboratory data. The program is one of sixteen National Cancer Institute funded phase I clinical pharmacology programs in the United States. Our program has been successful in the clinical development of several new cytotoxic chemotherapy and biologic agents currently utilized in clinical practice.

OUR TEAM APPROACH:

Members of the Phase I Clinical – Pharmacology Team evaluate their patients for potential treatment on clinical trials with careful attention. Members of this program represent different clinical sub specialties and work as a team by discussing together best treatment options for individual patients and the progress of such patients while on study. This activity takes place at the weekly Wednesday afternoon conferences, when investigators from Medical Oncology, Pharmacology and Investigational Pharmacy discuss individual treatment recommendations and the follow up for each patient. Treatment recommendations are discussed with the patient, their families and their referring physicians. All experimental treatments are conducted under specific Wayne State University Institutional Review Board approval and KCI scientific peer-review approval.

PATIENT ELIGIBILITY:

The multispecialty Phase I Clinical – Pharmacology team approach is most beneficial to: 

• Patients with advanced, often refractory, malignancies who are interested in pursuing experimental treatments for their cancer. 
   
• Patients with previously untreated and advanced malignancies for whom the present standard of care is poor and who wish to undergo novel treatments for their cancers. 
   
• Patients with advanced cancer who believe are physically, emotionally, and psychologically able to undergo additional treatments for their advanced cancer.

ON APPOINTMENT DAY:

On the day of the appointment, patients will receive close personal attention from the staff and faculty members of the Phase I Clinical –Pharmacology Team. A physician member of the team will evaluate the patient, review all records, and discuss treatment recommendations. Patients may be asked for their permission to obtain additional medical records. Some baseline testing will be could be done and the patient’s situation will be brought up for discussion at the next weekly team meeting. After the treatment recommendation is agreed to by the team, the patient is presented with the appropriate information on the treatment and the related consent forms for patient’s consideration. Due to the complicated nature of experimental therapies, it may take several weeks from the time of the initial appointment to day of treatment.

QUALIFICATIONS OF THE PHASE I TEAM MEMBERS:

Physician members of the Phase I Clinical – Pharmacology are highly experienced physicians with expertise in the treatment of patients with experimental therapies. Dr. Patricia LoRusso, D.O., Professor of Medicine, Director of the Phase I Clinical – Pharmacology Team is an expert in the multidisciplinary care of breast cancer and has been instrumental in leading the group to quickly develop many of the novel agents used today in the clinic. Dr. Valdivieso, M.D., Professor of Medicine, Chief Medical Officer of the Barbara Ann Karmanos Cancer Institute, has expertise in phase I and other experimental clinical trials as well as the multidisciplinary care of patients with cancers of the lung. Dr. Elisabeth Heath, M.D., Assistant Professor of Medicine, has expertise in clinical trials and in the treatment of multidisciplinary care of patients with genitourinary and upperaerodigestive cancers. These physician team members have published many articles and book chapters in their respective areas of expertise and are nationally and internationally recognized for their contributions. Additional vital members of the team include Lisa Malburg, C.NP. and Mary Jo Pilat, Ph.D., PA-C. Lisa Malburg, certified nurse practitioner, has been a dedicated nurse in the oncology field for 15 years. She is certified by the American Nurses Association as an adult NP and by the Oncology Nursing Society as an Advanced Oncology Certified Nurse. Mary Jo Pilat, Ph.D., PA-C has expertise as a certified physician assistant instrumental in caring for phase I patients. She also has valuable prior experience in the laboratory with regards to pre-clinical research.

TEAM COMPOSITION:

Patricia LoRusso, D.O., (Team Leader) D.O. Medical Oncology
Shirish Gadgeel, M.D., Medical Oncology
Elisabeth Heath, M.D., Medical Oncology
Amy Weise, D.O., Medical Oncology
Elizabeth Wood, Executive Director, Phase I Program

Carolyn Blackman, RPh., RN - Investigational Pharmacy
Margaret Houlehan, MSPAS, PA-C, Research Physician Assistant
Lisa Malburg, MSN, RN, NP, AOCN, Oncology Nurse Practitioner
Barbara Manica, R.Ph., Investigational Pharmacy
Mary Jo Pilat, Ph.D., M.S., PA-C, Research Physician Assistant
Carolyn Shearer, PA-C, Physician Assistant
Denise Weiss, APRN, BC, Nurse Practitioner

CLINICAL TRIALS:

When appropriate, patients will be given the opportunity to participate in a number of national and local clinical research trials. All experimental drug therapies will be conducted in clinical research trials. Many of the clinical trials will require additional blood work, radiology tests, and tissue biopsies.

 

HOW TO MAKE AN APPOINTMENT:
Referring physicians or patients may call (800) KARMANOS (800-527-6266) during regular business hours. A specially trained program coordinator is available to answer questions and schedule appointments.

The day of the appointment, patients are asked to bring the following: 

• Medical records detailing their previous cancer treatments. 
   
• Radiology studies including chest x-rays, CAT scans of the body, PET scans, MRI scans of brain, and bone scans, if available and their reports. 
   
• Pathology slides and reports.

OUR LOCATION:

The Multidisciplinary Phase I Clinical – Pharmacology Team is an integral part of the Developmental Therapeutics Program of KCI and it is located within the Barbara Ann Karmanos Cancer Institute’s Wertz Center. Valet parking and ample security are provided.