IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma
NCT ID: NCT00294476
Last Updated: 2006-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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IVIG
Biological Therapy
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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GammaCan
INDUSTRY
Principal Investigators
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Dan Aderka, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oncology institute, Sheba Madical Center
Locations
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Ella Institute, Oncology institute, Sheba Medical Center
Tel Litwinsky, Ramat Gan, Israel
Oncology Institute, Sheba Medical Center
Tel Litwinsky, Ramat Gan, Israel
Oncology institute, Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Facility Contacts
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Jacob Schachter, M.D
Role: primary
Dov Barak, R.N.
Role: backup
Dan Aderka
Role: primary
Dov Barak, R.N.
Role: backup
Alberto Gabison, M.D.
Role: primary
Rama Sapir, M.Sc.
Role: backup
Other Identifiers
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GCan-01
Identifier Type: -
Identifier Source: org_study_id