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

GammaCan

Status and phase

Unknown

Phase 2

Conditions

Cancer of Colon

Malignant Melanoma

Urologic Cancer

Treatments

Drug: IVIG

Procedure: Biological Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00294476

GCan-01

Details and patient eligibility

About

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.

Full description

This study is a one arm, open label, multi-center, phase II study. Its aim is to evaluate the safety and efficacy of IVIG administered as treatment for metastasis solid tumors. IVIG was proven as affecting the growth of tumor metastasis in animals' models.

Study population is including male or female, 18 and older, diagnosed as having a primary tumor (colon, melanoma or prostate) with measurable metastasis (according to the RECIST criteria) in soft tissues and/ or tumor markers in prostate cancer, for which there is no better alternate treatment.

The patients receive the IVIG calculated as 1g/kg/bodyweight per cycle (defined as every 21 days) until progression disease is noted. All patients are being followed for a period of 6 months after patient's withdrawal.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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