Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurr… (NCT00553683) | Clinical Trial Compass
UnknownPhase 1/2
Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
United States50 participantsStarted 2007-10
Plain-language 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. 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall tolerability
Timeframe: up to 90 days
Trial details
NCT IDNCT00553683
SponsorRutgers, The State University of New Jersey