Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Pemetrexed

Interferons

Interferon-alpha

Intrapleural SCH 721015 (Ad.hIFN-α2b) instilled over 2-5 minutes on Days 1 and 4. Chemotherapy administered for 4 to 6 cycles Subjects with malignant pleural mesothelioma who have been previously untreated with chemotherapy

Intrapleural SCH 721015 (Ad.hIFN-α2b) instilled over 2-5 minutes on Days 1 and 4. Chemotherapy administered for 4 to 6 cycles Subjects with malignant pleural mesothelioma who have been previously treated with chemotherapy

SCH 721015

Andrew Haas, MD, PhD

The purpose of this study is to find the safety of combination gene therapy and chemotherapy in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then pts will receive 2 doses of intrapleural vector followed by front line or second line chemotherapy 4-6 cycles every 21 days.

Malignant pleural mesothelioma (MPM) is a cancer for which there is no cure. The most effective combination chemotherapy, Pemetrexed (Alimta)/Cisplatin, has yielded overall response rates of up to 40%, but with improvements in overall median survival of only 3.5 months. Prior Phase I trials of intrapleural infusion (IP) of Ad.hIFN-beta (BG00001) were safe. The most recent trial of IP Ad.IFNalpha (SCH 721015) at a dose of 3e11 viral particles (vp) given three days apart was safe and well tolerated, and showed high levels of IFN in pleural fluid and serum. Our preclinical data modeling this proposed study suggest that two IP doses of Ad.IFN-alpha in combination with chemotherapy are well tolerated and markedly enhances efficacy. The purpose of the new study is to determine the safety of administrating intrapleural SCH 721015 (Ad.hIFN-alpha 2b) in combination with chemotherapy for the management of malignant pleural mesothelioma. This study will enroll subjects with pleural mesothelioma. Subjects will receive two fixed dosed of SCH 721015 followed by 4-6 cycles of chemotherapy. Subjects will require placement of a pleural catheter for administration of SCH 721015.

Some patients require a pleural catheter for control of pleural fluid while some will have it placed for research purpose only. Protocol participation is up to 15 years.

Combination Gene Transfer and Chemotherapy

A Pilot And Feasibility Trial Evaluating Two Different Chemotherapy Regimens In Combination With Intrapleural Adenoviral-Mediated Interferon-Alpha Gene Transfer For Malignant Pleural Mesothelioma

No dose escalation is planned; however, dose de-escalation is possible should two or more DLTs be encountered in the first six patients treated. With 0 DLTs in 6 patients at a given dose, the upper exact 90% confidence limit on the DLT rate is 32%. With 1 DLT in 6 patients, the Bayesian upper 90% probability limit on the DLT rate is 58%. With 10 subjects per treatment group, we can identify with 90% power any unanticipated toxicity that has prevalence at least 20.6%; with n=15 per group, this figure decreases to 14.2%.

Will estimate response rates by 95% confidence intervals, whose half-width will range from as low as 26% (if n=15 subjects are enrolled) to 32% (if n=10).

Will summarize the distributions of time to progression (TTP) and time to death from any cause by Kaplan-Meier curves. In analyses of TTP, subjects who die without progression will be considered censored at the time of death. Further secondary goals include the evaluation of immunologic indicators of response, including systemic and intrapleural cytokines and cellular and humoral immune responses.

Abramson Cancer Center at Penn Medicine

Interferon alpha-2

Interferon-alfa-1b

Antiviral Agents

Immunologic Factors

1.0 x 10e12 viral particles on Days 1 and 4

3.0 x 10e11 viral particles on Days 1 and 4

Daniel Sterman

This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in subjects with pleural mesothelioma.

Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation. Subjects are then followed-up as outpatients for a total of 6 months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is removed once it is not necessary.

Intrapleural Gene Transfer for Pleural Mesothelioma

A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma

National Cancer Institute (NCI)

Pleural Effusion

Pleural Diseases

Immunomodulating Agents

Interferon-beta

BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8

Adenoviral-mediated Interferon-beta

Comparison of different doses and frequency of investigational agent

Daniel H. Sterman, M.D.

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:

* malignant pleural mesothelioma, or
* pleural effusions who have progressed through at least one prior therapy or have refused therapy

BG00001 is given twice through a catheter in the pleural space.

Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.

Five dose levels will be studied:

* Dose levels 1, 2, and 3 will be given on Days 1 and 15
* Dose levels 4 and 5 will be given on Days 1 and 8

Gene Therapy for Pleural Malignancies

A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

Biogen

University of Pennsylvania

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

BCG Vaccine

Part1: 2 Instillations of intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume

Part 2: Subjects who have a complete response to treatment at Week 12 in Part 1 receive second regimen of intravesical administration of SCH 721015 with Syn3 on same Day 1 and Day 4 regimen at same dose level.

Intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume. Administered into bladder through a urinary catheter, 75 mL will be instilled, left in the bladder for 1 hour, plus or minus 10 minutes. During the dwell time, subject will be repositioned from left to right, back and abdomen to maximize bladder surface exposure, approximately every 15 minutes.

Colin P. Dinney, MD

The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.

The Study Drug:

SCH 72105 is designed to cause "gene transfer" by giving a gene called interferon -alpha-2b into the body. SCH 72105 is made after being processed in the lab with a study drug called Syn3. This combination of study drugs is also called SCH 721015 with Syn3. Syn3 is designed to help the body make a protein called interferon -alpha-2b, and this may help the body's immune system to react against the cancer.

Study Drug Administration:

On Days 1 and 4, SCH 72105 will be given into your bladder over about 1 minute through a urinary catheter. A urinary catheter is a thin flexible tube placed through the urinary tube and into the bladder. SCH 72105 will stay in the bladder for about 1 hour. You will be asked to turn from left to right, back to stomach, every 15 minutes to allow the bladder surface to be exposed to the drug.

A belladonna and opium (B\&O) suppository will be inserted into your rectum about 30 minutes before the study drug doses. Levsin SL (hyoscyamine sulfate) will be given by mouth about 15 minutes before the study drug doses. These drugs are used to lower the risk of urinary urgency (a strong need to urinate).

Study Visits:

On Day 1:

* Blood (about 3 teaspoons) will be drawn for routine tests.
* Urine will be collected to test for IFN levels and to check for infection.
* Your vital signs will be measured before and after the study drug dose.
* You will be asked about any side effects and urinary symptoms you may have had and any drugs you may be taking.
* Your performance status will be recorded.

On Days 2 and 3 and on Days 5-14:

* Urine will be collected for biomarker testing. Biomarkers in your urine may be related to your reaction to the study drug.
* Your performance status will be recorded.
* You will be asked about any side effects and urinary symptoms you may have had and any drugs you may be taking.

On Day 4:

* Blood (about 3 teaspoons) will be drawn for routine tests.
* Urine will be collected for biomarker testing and to check for infection.
* Your vital signs will be measured before and after the study drug dose.
* You will be asked about any side effects and urinary symptoms you may have had and any drugs you may be taking.
* Your performance status will be recorded.

During Days 1-11, you will add about 1/2 cup of bleach to the toilet bowl before every time you urinate. You will then wait 15 minutes before flushing. You should avoid public bathrooms on these days. This procedure is required to avoid exposing other people to the study drug.

One (1) time a week during Weeks 2-11, the study staff will call and ask you about any side effects and urinary symptoms you may have had and any drugs you may be taking. During these calls, your performance status will also be recorded.

At Week 12:

* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* Urine will be collected for biomarker testing and to check for infection.
* Your vital signs will be measured.
* You will have an ECG. This ECG will be used as a screening test to help the doctor decide if you are eligible to take part in Part 2 of the study.
* Your performance status will be recorded.
* You will be asked about any side effects and urinary symptoms you may have had and any drugs you may be taking.
* You will have a cystoscopy with biopsies to check the status of the disease. All areas that the doctor thinks might have a tumor will be biopsied. Your bladder will also be measured during this procedure.

Length of Participation:

You may receive the 2 doses of the study drug as planned, if the doctor thinks it is in your best interest. You will not be able to receive the second dose of the study drug if the disease gets worse or intolerable side effects occur.

Part 2 of the Study:

If the disease has completely responded by Week 12 (no sign of cancer), you will be asked to take part in Part 2 of this study. In Part 2, participants will receive another 2 doses of the study drug. There is a separate informed consent form that describes Part 2, including screening tests that will help the doctor decide if you are eligible. You will be asked to sign the informed consent form if you agree to take part.

The level of effectiveness of SCH72105 treatment will be studied by measurement of IFN levels in the daily urine collections.

End-of-Study Visit:

You may choose to stop your study participation at any time. If you choose to stop before the Week 12 visit, you will be asked to return for an end-of-study visit. You will also be called by the study staff to ask about your health 1 time a year for the next 2 years. The following tests and procedures will be performed at the end-of-study visit:

* You will have a physical exam.
* You will have an ECG.
* Urine will be collected for routine tests.

Follow-Up:

If you had any signs of bladder cancer at Week 12, the study staff will call you at Months 6, 9, 12, 24, and 36. You will be asked if you have had any serious side effects.

This is an investigational study. SCH 72105 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 9 patients will take part in this study (9 total, for Parts 1 and 2). All will be enrolled at MD Anderson.

1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer

Phase 1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Gene Transfer and Chemotherapy	NCT01119664	Mesothelioma	SCH 721015	18 Years -	Abramson Cancer Center at Penn Medicine
Intrapleural Gene Transfer for Pleural Mesothelioma	NCT01212367	Malignant Pleur...	SCH 721015 SCH 721015	18 Years -	Abramson Cancer Center at Penn Medicine
Gene Therapy for Pleural Malignancies	NCT00299962	Pleural Mesothe... Metastatic Pleu...	Adenoviral-medi... SCH 721015	18 Years -	University of Pennsylvania
1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer	NCT01162785	Bladder Cancer	SCH 721015	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for sch 721015

Every month we try and update this database with for sch 721015 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sch 721015

Every month we try and update this database with for sch 721015 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sch 721015 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.