Purpose: The main purpose of this study is to compare two types of care – standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients’ and caregivers’ quality of life, mood, coping and understanding of their illness.
Peritoneal Mesothelioma
SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
Purpose:
- Background:
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- Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body’s internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for all kinds of mesothelioma, so researchers are searching for new ways to treat it.
- Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how safe and effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.
- Objectives:
- To study the safety and effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.
- Eligibility:
- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.
- Design:
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- Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
- The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
- In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
- On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
- Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
- Participants will have regular followup visits as directed by the study doctors….
Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy
Purpose: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.
Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
- Background:
- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.
- Objectives:
- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
- Eligibility:
- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
- Design:
-
- * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies.
- * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed.
- * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.
Quality of Life and Survivorship Care in Patients Undergoing HIPEC (HOPE)
Rationale: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies.
Purpose: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.
- Arm I: Experimental
- Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.
Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
Purpose: Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient’s will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.
Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
Purpose: The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.
AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Rationale: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Purpose: This phase II trial is studying how well AZD2171 works in treating patients with malignant mesothelioma that cannot be removed by surgery.
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma
Purpose: The purposes of this study are to determine:
- The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
- Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.
- Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
- To see if patients feel better while taking Pemetrexed plus Gemcitabine.
