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

October 11, 2006 updated by: GammaCan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Oncology institute, Shaare Zedek Medical Center
        • Contact:
          • Alberto Gabison, M.D.
          • Phone Number: 972-2-6555036
        • Contact:
          • Rama Sapir, M.Sc.
          • Phone Number: 972-2-6555727
        • Principal Investigator:
          • Alberto Gabison, M.D.
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • Recruiting
        • Ella Institute, Oncology institute, Sheba Medical Center
        • Contact:
          • Jacob Schachter, M.D
          • Phone Number: 972-3-5302243
        • Contact:
          • Dov Barak, R.N.
          • Phone Number: 972-3-5305201
        • Principal Investigator:
          • Jacob Schachter, M.D.
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • Recruiting
        • Oncology Institute, Sheba Medical Center
        • Contact:
          • Dov Barak, R.N.
          • Phone Number: 972-3-5305201
        • Contact:
          • Dan Aderka
          • Phone Number: 972-3-5305259
        • Principal Investigator:
          • Dan Aderka, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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
and Serum tumor markers as appropriate CEA, PSA. Additionally, ECOG performance status is evaluated before each treatment cycle

Secondary Outcome Measures

Outcome Measure
Secondary efficacy measurements: Overall survival, Karnofsky Performance Status is evaluated at baseline and before each treatment cycle and Quality of life questionnaires is completed and evaluated at baseline and every 3 treatment cycles (9 weeks)
Safety assessments include Adverse events and laboratory values which are measured and evaluated before every treatment cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GammaCan

Investigators

  • Principal Investigator: Dan Aderka, M.D., Oncology institute, Sheba Madical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

February 19, 2006

First Submitted That Met QC Criteria

February 19, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2006

Last Update Submitted That Met QC Criteria

October 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCan-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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