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

NCT00294476 | Unknown Phase 2

• 1 other identifier: GCan-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer of Colon; Malignant Melanoma; Urologic Cancer

Keywords

IVIg; Cancer; Melanoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

IVIG DRUG

Biological Therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GammaCan: lead

Study Sites (3)

Ella Institute, Oncology institute, Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

RECRUITING

Oncology Institute, Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

RECRUITING

Oncology institute, Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Melanoma; Urologic Neoplasms; Neoplasms

Interventions

Immunoglobulins, Intravenous; Biological Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Dan Aderka, M.D.

  Oncology institute, Sheba Madical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2006
• First Posted: February 22, 2006
• Study Start: July 1, 2005
• Last Updated: October 12, 2006

Record last verified: 2006-09

Locations

IL (3)