There may be risks of side-effects from study treatment (study drug or study chemotherapy drugs) on this study or from some of the procedures or tests that will be done. Also, your cancer condition may get better, but it could stay the same or even get worse.
Below you will find the most common side effects doctors know about for the study drug (oregovomab) being studied and the chemotherapy drugs (paclitaxel and carboplatin). Keep in mind that there might be other side effects doctors do not yet know about. If important new side effects are found, the Study Doctor will discuss these with you.
Oregovomab known side effects when given alone:
Infusion-related reactions are the most common side effects known for the study drug oregovomab when it is taken alone. Infusion-related reactions include reactions such as flushing (warmth and reddening of skin), rash, fever, rigors (feeling of cold with shivering), chills, shortness of breath, and mild low blood pressure. Infusion-related reactions were seen in 20% or more of the patients who received the drug in the past, but for the majority of the cases, they were mild, easily managed and generally prevented when pre-medications were taken by patients before they received oregovomab.
Side effects of combination (Oregovomab, paclitaxel and carboplatin):
There have been several different side effects seen in previous studies when oregovomab was given with paclitaxel and carboplatin. Possible side effects could include Anemia (person does not have enough healthy red blood cells to carry adequate oxygen to his or her body's tissues), Leukopenia (person has fewer white blood cells in their bloodstream than they should),
Neutropenia (person has a low level of white blood cells called neutrophils),
Thrombocytopenia (person has low platelet levels),
Paresthesia (tingling ‘pins and needles’ feeling),
Peripheral sensory neuropathy (nerve damage outside of the brain and spinal cord, often causes weakness, numbness and pain, usually in your hands and feet), and Alopecia (hair loss).
The more uncommon side effects seen in less than 5% of patients include arthralgia (joint pain) and myalgia (muscle pain).