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

Primary Purpose

Cancer of Colon, Malignant Melanoma, Urologic Cancer

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
IVIG
Biological Therapy
Sponsored by
GammaCan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Colon focused on measuring IVIg, Cancer, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ella Institute, Oncology institute, Sheba Medical CenterRecruiting
  • Oncology Institute, Sheba Medical CenterRecruiting
  • Oncology institute, Shaare Zedek Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 19, 2006
Last Updated
October 11, 2006
Sponsor
GammaCan
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1. Study Identification

Unique Protocol Identification Number
NCT00294476
Brief Title
IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GammaCan

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Malignant Melanoma, Urologic Cancer
Keywords
IVIg, Cancer, Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IVIG
Intervention Type
Procedure
Intervention Name(s)
Biological Therapy
Primary Outcome Measure Information:
Title
1. Tumor response is measured at baseline and evaluated every 3 treatment cycles (9 weeks) by RECIST(CT or MRI measurements), Time to Progression
Title
and Serum tumor markers as appropriate CEA, PSA. Additionally, ECOG performance status is evaluated before each treatment cycle
Secondary Outcome Measure Information:
Title
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)
Title
Safety assessments include Adverse events and laboratory values which are measured and evaluated before every treatment cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Aderka, M.D.
Organizational Affiliation
Oncology institute, Sheba Madical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ella Institute, Oncology institute, Sheba Medical Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Schachter, M.D
Phone
972-3-5302243
First Name & Middle Initial & Last Name & Degree
Dov Barak, R.N.
Phone
972-3-5305201
First Name & Middle Initial & Last Name & Degree
Jacob Schachter, M.D.
Facility Name
Oncology Institute, Sheba Medical Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Aderka
Phone
972-3-5305259
First Name & Middle Initial & Last Name & Degree
Dov Barak, R.N.
Phone
972-3-5305201
First Name & Middle Initial & Last Name & Degree
Dan Aderka, M.D
Facility Name
Oncology institute, Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Gabison, M.D.
Phone
972-2-6555036
First Name & Middle Initial & Last Name & Degree
Rama Sapir, M.Sc.
Phone
972-2-6555727
First Name & Middle Initial & Last Name & Degree
Alberto Gabison, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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