Cancer of ColonPhase 2NCT00294476
IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma
A Phase 2 study testing IVIG and Biological Therapy in people with Cancer of Colon and Malignant Melanoma, run by GammaCan at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Colon, Malignant Melanoma, Urologic Cancer
- What is being tested?
- IVIG and Biological Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- Jul 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Oncology institute, Shaare Zedek Medical Center
Jerusalem
Alberto Gabison, M.D., 972-2-6555036
Rama Sapir, M.Sc., 972-2-6555727
- Recruiting
Ella Institute, Oncology institute, Sheba Medical Center
Tel HaShomer, Ramat Gan, 52621
Jacob Schachter, M.D, 972-3-5302243
Dov Barak, R.N., 972-3-5305201
- Recruiting
Oncology Institute, Sheba Medical Center
Tel HaShomer, Ramat Gan, 52621
Dan Aderka, 972-3-5305259
Dov Barak, R.N., 972-3-5305201
About this study
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
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.
Read the 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.
- Conditions
- Cancer of Colon, Malignant Melanoma, Urologic Cancer
- Being tested
- IVIG, Biological Therapy
- Keywords
- IVIg, Cancer, Melanoma
- Medical subject headings
- Colonic Neoplasms, Melanoma, Urologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Biological TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- GammaCan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Aderka, M.D., Principal investigator, Oncology institute, Sheba Madical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294476
- Sponsor's protocol ID
- GCan-01
- Status last verified
- Sep 2006
- First submitted
- 19 Feb 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00294476
- Acronym / sponsor ID
- GCan-01
- Conditions
- Cancer of Colon, Malignant Melanoma, Urologic Cancer
- Keywords
- IVIg, Cancer, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- GammaCanIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG | Drug | – |
| Biological Therapy | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Aderka, M.D. principal investigator
Oncology institute, Sheba Madical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVIG and Biological Therapy in people with Cancer of Colon and Malignant Melanoma, run by GammaCan at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2006.