A One Arm, Open Label,Multi - Center Phase II Study to Evaluate the Safety and Efficacy of IVIG in the Treatment of Various Metastatic Solid Tumors for Which There is no Better Alternate Treatment
- Patients older than 18 years of age.
- Histological confirmed diagnosis of a prostate adenocarcinoma, melanoma or colon
- At least one measurable site of disease as evidenced by CT or MRI, RECIST criteria in
soft tissue OR lymph nodes and OR tumor markers as appropriate
- Rising PSA in 3 consecutive weeks taken at least one week apart with a value of at
least 5 ng/mL
- Testosterone that is less than 50 ng/dL in prostate patients
- Prostate cancer patients receiving radiation therapy that is less than 30% of
pelvic/total bone mass and where acute radiation toxicity is resolved
- ECOG Performance status 0- 2
- WBC > 1,500 cells/mm3, hemoglobin > 9 g/dL, and platelets > 100,000 cells/mm3 and <
- Adequate renal function: serum creatinine < 2.0 mg/dL, or CCT>= 50 ml/min
- Life expectancy of at least 3 months
- Willing to participate in a 6 month follow-up
- Female patients of child-bearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Post menopausal women must be
amenorrheic for at least 12 months to be considered of non- childbearing potential.
Male and female patients of reproductive potential must agree to employ an effective
barrier method of birth control throughout the study and for up to 3 months following
discontinuation of study drug.
- Patients who have given written informed consent
- Patients suffering from primary or metastatic brain or spinal tumor.
- Patients with known sensitivity to any of the components of the IVIG formulation
- IgA levels <=60mg/dl .
- Treatment with IVIG 6 months prior to study start
- Patients that are with known seropositivity for HIV or with a known diagnosis of
human immunodeficiency virus (HIV) infection. (AIDS)
- Patients with significant diseases, active infection or uncontrolled medical
condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal,
genitourinary) considered high risk for investigational new drug treatment/ who in
the opinion of the investigator would be excluded from the study
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled renal failure.
- Patient has known chronic liver disease (i.e., chronic active hepatitis, and
- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent and who in the opinion of investigator,
are unlikely to comply with the study protocol
- Patients who are currently participating or have participated in another clinical
trial in the last 30 days.
- Patients who have undergone chemotherapy in the last 4 weeks
- Patients who are being treated with antibiotic treatment for an active infection