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CLINICAL TRIALS

If you currently have a patient that may be eligible for enrollment into any of these exciting trials, please contact us at 401-456-2464. Do not hesitate to call with any questions.

HEPATIC IMMUNOTHERAPY FOR METASTASES (HITM)
PHASE I TRIAL FOR PATIENTS WITH ADENOCARCINOMA
LIVER METASTASES (NCT01373047)

Click here to enroll in this trial.

Brief Summary
The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic arterial circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. We hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.

Detailed Description
T cells have the power to destroy malignant cells under certain conditions, as demonstrated by the rare spontaneous remissions of cancer. However, the endogenous T cell response to cancer fails in the vast majority of patients and the tolerogenic conditions within the liver may pose additional immunologic barriers for those with intrahepatic metastases. We modify patient T cells to kill malignant cells based on their expression of tumor antigens using antibody-defined recognition. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. Prior studies in model systems demonstrated that recombinant IgCD28TCR (see figure above) could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity - the hallmarks of an effective, self-sustaining immune response.

The present trial will test the regional infusion of anti-CEA designer T cells, given via the hepatic artery using a percutaneous approach (see adjacent figure). This is an intra-patient dose escalation trial, where patients will receive three doses over the course of six weeks. Doses are 10^8, 10^9 and 10^10 modified T cells. Patients are monitored for safety and response. Patients are on-study for one month after dosing. Patients undergo phlebotomy or leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated in culture, and then transduced with retrovirus expressing the anti-CEA IgCD28TCR. Cells are expanded in culture and returned to the patient by percutaneous hepatic artery infusion at specific cell doses. Prior to the first dose, each patient will undergo diagnostic angiography to verify suitable arterial anatomy. Three doses per patient are planned at 2 week intervals.
    Inclusion Criteria:
  • Histologically confirmed diagnosis of CEA+ adenocarcinoma and liver metastases
  • Liver metastases must be CEA-expressing as demonstrated by elevated serum CEA levels (≥10ng/ml)
  • or immunohistochemistry on a biopsy specimen
  • Failure on at least one line of standard systemic chemotherapy and have unresectable liver disease
  • Measurable liver disease (> 1.0 cm by CT or MRI)
  • Extrahepatic disease is acceptable when limited to the lungs and/or abdominal lymph nodes
  • At least 18 years of age
  • Able to understand and sign informed consent
  • Life expectancy of greater than four months
  • Good performance status (PS 0-1)
    Exclusion criteria:
  • Pregnancy
  • Serious medical conditions including but not limited to liver, cardiopulmonary, and renal disease
  • Patients with a history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis
  • Concurrent malignancy
  • Use of systemic steroids
Learn more about this trial here.

GASTROINTESTINAL STROMAL TUMOR (GIST) OPEN GIST TRIAL (NCT00867113)
We are pleased to announce our participation in an important trial addressing the duration of imatinib mesylate (Gleevec®) therapy for patients with gastrointestinal stromal tumors (GIST). As you know, the ability of imatinib to lower the risk of recurrence following surgical removal of GIST is profound. Yet, the appropriate duration of imatinib therapy following resection is not yet determined. The Roger Williams Cancer Center is pleased to offer access to this national trial, which addresses this important clinical question. This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 133 adult patients will be enrolled. Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 5 years for survival, recurrence, and quality of life. The drug is available to enrolled patients for 5 years at no cost. Enrollment is competitive and the trial will be closed after the target is reached.

Inclusion & Exclusion Criteria Highlights:
Age ≥ 18; Histological GIST diagnosis and CD117 (KIT) positive tumor; Primary GIST (any site) ≥ 2cm & ≥5 mitoses/50 HPF OR non-gastric primary GIST ≥ 5cm Complete gross resection of primary GIST within 12 weeks of enrollment; No evidence of metastatic GIST on CT or MRI ECOG performance status of 0 or 1; All prior malignancies treated with potentially curative therapy and free of recurrence for ≥ 3 years; Patients with grade III/IV cardiac problems are excluded; Patients being treated with warfarin are excluded.

PANCREAS CANCER OPEN PANCREATIC CANCER TRIAL (NCT00569387)
We are pleased to announce our participation in an important trial for patients with pancreas adenocarcinoma. As you know, even for those patients with pancreatic adenocarcinoma who are able to undergo potentially curative resection, the majority with recur and die of disease. Our presently available systemic treatments are inadequate. We and others believe that immunotherapy holds great promise for the treatment of pancreatic cancer. The present trial offers an innovative approach to a daunting disease - the HyperAcute®-Pancreatic Cancer Vaccine in combination with chemotherapy and chemoradiotherapy. A vaccine consisting of an inactivated pancreatic cancer cell line expressing murine glycoproteins will be given in conjunction with gemcitabine and chemoradiotherapy following resection. This is a Phase II, non-randomized, multi-center study. The primary endpoint is time to recurrence. Secondary endpoints are the extent of the immune response induced by the vaccine and overall survival. A total of 71 adult patients will be enrolled. Participants will undergo five cycles of treatment following surgery, including vaccination X 5, chemotherapy X 5, and chemoradiotherapy.

Inclusion & Exclusion Criteria Highlights:
A histological diagnosis of adenocarcinoma of the pancreas. AJCC Stage I or II Pancreatic carcinoma; Patients must have undergone surgical resection for the tumor and extent of resection must be either R0 (complete resection) or R1 (grossly negative but positive microscopically margins of resection); Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; Expected survival ≥ 6 months. Serum albumin ≥ 2.0 gm/dL; Patients with other malignancies within five years, unless the probability of recurrence of the prior malignancy is <5%,are excluded; Patients with active metastases are excluded.