Breast CancerPhase 1/2NCT00553683
Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
A Phase 1/2 study testing cyclophosphamide, poly ICLC and hepatic artery embolization in people with Breast Cancer and Colorectal Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Gastric Cancer
- What is being tested?
- cyclophosphamide, poly ICLC and hepatic artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2014
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Radiologically or histologically confirmed hepatocellular carcinoma
- Stage III or IV primary disease
- Recurrent, unresectable, or metastatic disease meeting any of the following criteria:
- Pancreatic cancer that underwent prior surgical resection and progressed with recurrent metastatic disease to the liver
- Gastric, colon, breast, or ovarian cancer or melanoma with metastatic disease to the liver
- Primary or recurrent disease that cannot be surgically resected leaving the patient disease-free
- Radiologically measurable disease
- Ineligible for liver transplantation according to University of San Francisco listing criteria:
- Single lesion > 6.5 cm
- Three or more tumors > 4.5 cm
- Cumulative tumor diameter > 8 cm
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- ANC ≥ 1,500/mm³
- Platelets ≥ 75,000/mm³
- Creatinine ≤ 1.7 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 3 times the upper limit of normal
- INR < 1.5
- LVEF ≥ 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious concurrent infection or medical illness that would render the protocol treatment unsafe
- LVEF ≥ 50%
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgrers University Hospital
Newark, New Jersey, 07101
About this study
Official title: Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With Unresectable, Recurrent, or Metastatic Cancers in the Liver (Hepatoma, Cholangiocarcinoma, Neuroendocrine, Breast, Colon, Gastric, and Esophageal Cancer)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment for liver cancer.
PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide, radiation therapy, and poly ICLC together and to see how well they work in treating patients with unresectable, recurrent, primary, or metastatic liver cancer.
Read the detailed description
OBJECTIVES:
- To study the safety and effectiveness of a strategy to establish robust anticancer immunologic body defenses by using low-dose radiation therapy to the liver cancer in order to increase tumor targetability; inject a body defense activator, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol, oncovir), into and around the cancer to activate sentinel dendritic cells to alarm body defenses; and shut down local production of factors that suppress the body's natural anticancer defenses by starving the cancer of its blood supply within the liver.
OUTLINE: Patients receive low-dose oral cyclophosphamide once daily on days 1-21 and undergo 3-dimensional conformal radiotherapy on days 21-23. On day 24, patients undergo an intra- or peri-tumoral polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC) injection directly into the tumor followed by trans-hepatic artery embolization to the designated tumor. Patients receive poly ICLC subcutaneously on days 26, 35, 37, 42, 44, 49, and 51. Treatment repeats every 57 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
- Conditions
- Breast Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Melanoma (Skin), Metastatic Cancer
- Being tested
- cyclophosphamide, poly ICLC, hepatic artery embolization, 3-dimensional conformal radiation therapy
- Keywords
- stage IV pancreatic cancer, adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent pancreatic cancer, recurrent colon cancer, recurrent breast cancer, recurrent gastric cancer, recurrent ovarian epithelial cancer, recurrent melanoma, stage IV breast cancer, stage IV gastric cancer, stage IV colon cancer, stage IV ovarian epithelial cancer, stage IV melanoma, liver metastases
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Liver Neoplasms, Melanoma, Neoplasm Metastasis, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
poly ICLCDrug
hepatic artery embolizationProcedure or surgery
3-dimensional conformal radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| poly ICLC | Experimental | Not described Receives: Drug: cyclophosphamide; Drug: poly ICLC; Procedure: hepatic artery embolization; Radiation: 3-dimensional conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tolerability
Measured: up to 90 days
Secondary outcomes (2)
Progression-free survival at 6, 12, and 24 months
Measured: up to 24 months
Overall survival at 6, 12, and 24 months
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew de la Torre, Rutgers, The State University of New Jersey
- Investigators
- Andrew N. de la Torre, MD, Study chair, UMDNJ University Hospital / St Joseph Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553683
- Sponsor's protocol ID
- CDR0000573370
- Other IDs
- UMDNJ-0120070076
- Status last verified
- Jan 2014
- First submitted
- 2 Nov 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With Unresectable, Recurrent, or Metastatic Cancers in the Liver (Hepatoma, Cholangiocarcinoma, Neuroendocrine, Breast, Colon, Gastric, and Esophageal Cancer)
- ClinicalTrials.gov ID
- NCT00553683
- Acronym / sponsor ID
- CDR0000573370
- Conditions
- Breast Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Melanoma (Skin), Metastatic Cancer
- Keywords
- stage IV pancreatic cancer, adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent pancreatic cancer, recurrent colon cancer, recurrent breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 Nov 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment for liver cancer.
PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide, radiation therapy, and poly ICLC together and to see how well they work in treating patients with unresectable, recurrent, primary, or metastatic liver cancer.
Detailed description
OBJECTIVES:
- To study the safety and effectiveness of a strategy to establish robust anticancer immunologic body defenses by using low-dose radiation therapy to the liver cancer in order to increase tumor targetability; inject a body defense activator, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol, oncovir), into and around the cancer to activate sentinel dendritic cells to alarm body defenses; and shut down local production of factors that suppress the body's natural anticancer defenses by starving the cancer of its blood supply within the liver.
OUTLINE: Patients receive low-dose oral cyclophosphamide once daily on days 1-21 and undergo 3-dimensional conformal radiotherapy on days 21-23. On day 24, patients undergo an intra- or peri-tumoral polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC) injection directly into the tumor followed by trans-hepatic artery embolization to the designated tumor. Patients receive poly ICLC subcutaneously on days 26, 35, 37, 42, 44, 49, and 51. Treatment repeats every 57 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| poly ICLC | Experimental | Drug: cyclophosphamide, Drug: poly ICLC, Procedure: hepatic artery embolization, Radiation: 3-dimensional conformal radiation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cyclophosphamide | Drug | poly ICLC |
| poly ICLC | Drug | poly ICLC |
| hepatic artery embolization | Procedure or surgery | poly ICLC |
| 3-dimensional conformal radiation therapy | Radiation | poly ICLC |
Primary outcome
Overall tolerability
Time frame: up to 90 days
2 secondary outcomes
Progression-free survival at 6, 12, and 24 months
Time frame: up to 24 months
Overall survival at 6, 12, and 24 months
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Andrew N. de la Torre, MD study chair
UMDNJ University Hospital / St Joseph Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cyclophosphamide, poly ICLC and hepatic artery embolization in people with Breast Cancer and Colorectal Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall tolerability (time frame: up to 90 days). 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 14 Jan 2014.