VB-111+Paclitaxel for Recurrent Mullerian Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | April 2013 |
| End Date: | September 2019 |
| Contact: | Richard Penson, MD |
| Email: | rpenson@partners.org |
| Phone: | 6177244800 |
A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Mullerian Cancer
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.
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.
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.
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.
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
We found this trial at
3
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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