VB-111+Paclitaxel for Recurrent Mullerian Cancer
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Purpose
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved VB-111, or the combination of VB-111 with paclitaxel for use in patients, including people with your type of cancer.
VB-111 is designed to kill cancer cells in the body by "cutting off" the blood flow to cancer cells and/or tumors. The process of "cutting off" the blood flow to cancer cells and/or tumors is known as anti-angiogenesis and has been shown to help prevent tumor growth. VB-111 is both a vascular disrupting (blocking blood vessels) and anti-angiogenic (preventing new blood vessel growth) agent. It is different to normal chemotherapy as it is made from an adenovirus (Cold virus) carrying a human gene that kills cell lining blood vessels (Endothelial cells). This virus is a 'non-replicating' virus, meaning it cannot grow in the body.
Paclitaxel is a chemotherapy drug which is FDA approved for use in your type of cancer.
In this research study, we are looking for the highest dose of VB-111 that can be given safely in combination with paclitaxel to patients with platinum-resistant ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer Fallopian Tube Cancer Malignant Tumor of Peritoneum Papillary Carcinoma of Uterus Uterine Malignant Mixed Muellerian Tumour |
Drug: Paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Mullerian Cancer |
- Define Toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
- Response and Predictive Markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]Explore predictive markers of toxicity and response
| Estimated Enrollment: | 42 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | September 2019 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
Paclitaxel+VB-111
|
Drug: Paclitaxel
Chemotherapy
Other Name: Taxol
|
Detailed Description:
We are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants who have ovarian cancer. For this reason not everyone who participates in the research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
This study will be performed in cycles. Each cycle will be 28 days long. If you take part in this research study, you will receive VB-111 as a 15-minute intravenous infusion on Day 1 of odd cycles (e.g. every 2 cycles, or 2 months). VB-111 will be infused immediately following the paclitaxel.
You will receive paclitaxel as a 60-minute intravenous infusion weekly (days 1, 8, 15 and 22 of each 4 week cycle).
On Day 1 of each cycle you will undergo a medical history, physical exam, performance status, vital signs check, urine sample, routine blood tests, biomarker blood tests and biodistribution blood and urine tests. On Day 1 of each odd cycle you will undergo a CT scan or MRI to assess your tumor.
After the final dose of VB-111 you will be required to return to the clinic for a follow up visit. This visit will consist of a medical history, vital signs, physical examination, performance status, blood samples, urine samples, EKG and measurement of your tumor by CT or MRI. In the case of unexplained death, we will ask your family's permission for an autopsy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Up to 3 previous lines of chemotherapy for metastatic disease are allowed
- Must have had prior platinum or platinum based therapy
- Platinum resistant or refractory disease
- Measurable or evaluable disease
- Must have recovered from acute toxicity from prior treatment
Exclusion Criteria:
- Prior GI perforation or GI obstruction or involvement of the bowel on imaging
- Active untreated psychiatric disease or neurologic symptoms requiring treatment
- Known hypersensitivity to Cremophor EL
- Evidence of uncontrolled bacterial, viral or fungal infections
- Receiving other investigational therapy for the past 30 days before dosing
- More than 3 prior lines of chemotherapy for recurrent cancer
- Other active malignancy
- Inadequately controlled hypertension
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction or transient ischemic attack within 6 months
- Known CNS disease, except for treated brain metastasis
- Significant vascular disease
- History of hemoptysis within 1 month
- Evidence of bleeding diathesis or significant coagulopathy
- Major surgical procedure within 28 days
- Ongoing requirement for an immunosuppressive treatment
- Pregnant or breastfeeding
Contacts and Locations| Contact: Richard Penson, MD | 6177244800 | rpenson@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: RIchard Penson, MD 617-724-4800 rpenson@partners.org | |
| Principal Investigator: Richard Penson, MD | |
| Dana-Farber Cancer Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Suzanne Berlin, DO 617-632-5269 sberlin@partners.org | |
| Principal Investigator: Suzanne Berlin, DO | |
| Brigham and Women's Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Suzanne Berlin, DO 617-632-5269 sberlin@partners.org | |
| Principal Investigator: Suzanne Berlin, DO | |
| Principal Investigator: | Richard T Penson, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Richard Thomas Penson, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01801215 History of Changes |
| Other Study ID Numbers: | 11-418 |
| Study First Received: | August 21, 2012 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Papillary Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Mixed Tumor, Mullerian Carcinosarcoma Mixed Tumor, Mesodermal Neoplasms, Glandular and Epithelial Uterine Neoplasms Neoplasms by Histologic Type Neoplasms, Squamous Cell Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on May 22, 2013