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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

Phase 2
18 Years
Open (Enrolling)
Cancer of Colon, Malignant Melanoma, Urologic Cancer

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Trial Information

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

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.

Inclusion Criteria:

- 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 <
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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. Tumor response is measured at baseline and evaluated every 3 treatment cycles (9 weeks) by RECIST(CT or MRI measurements), Time to Progression

Principal Investigator

Dan Aderka, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology institute, Sheba Madical Center


Israel: Ministry of Health

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Cancer of Colon
  • Malignant Melanoma
  • Urologic Cancer
  • IVIg
  • Cancer
  • Melanoma
  • Colonic Neoplasms
  • Melanoma
  • Prostatic Neoplasms
  • Urologic Neoplasms