IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of IVIG in the treatment of metastatic cancer of the prostate, colon and melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GammaCan

Criteria

Inclusion Criteria:

• Patients older than 18 years of age.

• Histological confirmed diagnosis of a prostate adenocarcinoma, melanoma or colon cancer

• 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 < 500,000 cells/mm3

• 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

Exclusion Criteria:

• Patients suffering from primary or metastatic brain or spinal tumor.

• Patients with known sensitivity to any of the components of the IVIG formulation excipients.

• 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 cirrhosis).

• 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