Clinical trials at the Poliklinik Heidelberg
The Medizinische Klinik und Poliklinik V participates in a number of clinical trials to establish better treatment for different cancers and diseases. The clinical trials listed below are sorted according to the disease, against which each trial was designed for
Soft tissue sarcoma
High dose chemotherapy with peripheral blood stem cell rescue (PBSCR) in hogh risk patients with advanced soft tissue sarcoma in adults.
EORTC 62961/ESHO RHT-95 :
randomized study comparing neoadjuvant chemotherapy Etoposide + Ifosfamide + Adriamycin (EIA) combined with regional hyperthermia (RHT) versus neoadjuvant chemotherapy alone in the treatment of high-risk soft tissue sarcomas in adults.
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
This study is currently recruiting patients.
Sponsored by
Ludwig Maximillian Universitaet Women's Hospital
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer.
PURPOSE: Randomizedphase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrentovarian epithelial, fallopian tube, or peritoneal cancer.
Condition / Treatment or Intervention / PhaseFallopian Tube Cancer
peritoneal cavity cancer
recurrent ovarian epithelial cancer / Drug:carboplatin
Drug:ifosfamide
Procedure:chemotherapy
Procedure:hyperthermia / Phase II
Phase III
Cisplatin, Gemcitabine, Interferon alfa, and Hyperthermia in Treating Patients With Advanced Cancer unspecified adult solid tumor, protocol specific; phase I
This study is currently recruiting patients. Sponsored by University of Texas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia in treating patients who have metastatic, recurrent, or refractory cancer.
Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
This study is currently recruiting patients. Sponsored by
EORTC Soft Tissue and Bone Sarcoma Cooperative Group
European Society For Hypothermic Oncology
Adult soft tissue sarcoma, Phase III
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissuesarcoma.
PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without hyperthermia therapy in treating patients with soft tissue sarcoma.
Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients with Chest Wall Recurrence or Stage IV Disease with Locally Advanced Breast Cancer
This study is currently recruiting patients. sponsored by
National Center for Research Resources (NCRR)
Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response.
Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.
Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
This study is currently recruiting patients. Sponsored by
National Cancer Institute (NCI)
Purpose: Subjects of this study are cancer patients with lung tumors that cannot be removed by surgery and that have not spread elsewhere in the body. This study will evaluate an experimental surgical treatment called isolated lung perfusion that will treat tumors in the lung with a heated chemotherapy medicine called paclitaxel. The study will help determine whether this use of paclitaxel causes side effects and what dosage is safe.
To determine eligibility for the study, patients will undergo a physical exam, chest x-ray, electrocardiogram, and CT scan of chest, abdomen, and pelvis (and head, if necessary). Standard blood tests, including an arterial gas, and pulmonary function tests will be done. The chest x-ray and either arterial blood gas or measurement of blood oxygen level by finger probe will be repeated periodically after surgery. Pregnant or breastfeeding women will be excluded from the study.
Subjects will be admitted to the Clinical Center 24 hours before surgery. The operation will be performed under general anesthesia. A catheter passed from a neck vein into an artery in the lung, a catheter in the bladder, and electrodes on the chest will help monitor the fluid status and heart rhythm of the patient. A tube through the mouth into the lungs will let the patient breathe during the operation. An incision will be made down the middle of the chest or across the back to access the lung. The lung's blood supply will be separated from the rest of the body's by using catheters. A pump will flush the lung with fluid containing prostaglandin E to make the blood vessels relax. The pump will then push blood and paclitaxel through the lung for 90 minutes. (Patients entering early in the study will receive smaller doses than those entering later in the study.) Several medicines will be given to prevent an allergic reaction to the paclitaxel. The catheters will then be removed, the blood vessels reconnected, and the chest closed with sutures. The operation will last about 4 hours. Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
This study is currently recruiting patients.
Sponsored by
Focus Surgery
Purpose
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: Phase I trial to determine the effectiveness of focused ultrasound energy in treating patients who have locallyrecurrentprostate cancer.
Condition / Treatment or Intervention / Phasestage I prostate cancer
stage II prostate cancer
recurrent prostate cancer / Procedure:hyperthermia
Procedure:thermal ablation therapy / Phase I
Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
This study is currently recruiting patients.
Sponsored by
Ireland Cancer Center
National Cancer Institute (NCI)
Purpose
RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
Condition / Treatment or Intervention / Phasestage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
unspecified adult solid tumor, protocol specific
liver metastases / Procedure:hyperthermia
Procedure:radiofrequency ablation
Procedure:thermal ablation therapy / Phase II
Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
This study is currently recruiting patients.
Sponsored by
Celsion
Purpose
RATIONALE: Drugs used in chemotherapy, such as liposomaldoxorubicin, use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining liposomal doxorubicin with microwave thermotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with microwave thermotherapy in treating patients who have prostate cancer.
Condition / Treatment or Intervention / Phaseadenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer / Drug:doxorubicin HCl liposome
Procedure:chemotherapy
Procedure:hyperthermia / Phase I
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
This study is currently recruiting patients.
Sponsored by
Celsion
Purpose
RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature.
PURPOSE: Randomizedphase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.
Condition / Treatment or Intervention / Phasestage I breast cancer
stage II breast cancer / Procedure:conventional surgery
Procedure:hyperthermia
Procedure:neoadjuvant therapy
Procedure:surgery
Procedure:thermal ablation therapy / Phase II
Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
This study is currently recruiting patients.
Sponsored by
EORTC Gastrointestinal Tract Cancer Cooperative Group
Arbeitsgruppe Lebermetastasen und tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie
National Cancer Research Institute (NCRI)
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.
PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without radiofrequency ablation in treating unresectable liver metastases in patients who have colorectal cancer.
Condition / Treatment or Intervention / Phaseliver metastases
stage IV colon cancer
Stage IV rectal cancer / Drug:fluorouracil
Drug:leucovorin calcium
Drug:oxaliplatin
Procedure:chemotherapy
Procedure:conventional surgery
Procedure:hyperthermia
Procedure:radiofrequency ablation
Procedure:surgery
Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer
This study is currently recruiting patients.
Sponsored by
Celsion
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.
Condition / Treatment or Intervention / Phasestage IIIA breast cancer / Drug:cyclophosphamide
Drug:doxorubicin
Procedure:chemotherapy
Procedure:conventional surgery
Procedure:hyperthermia
Procedure:neoadjuvant therapy
Procedure:surgery
Procedure:thermal ablation therapy
Radiofrequency Ablation in Treating Patients With Bone Metastases
This study is currently recruiting patients.
Sponsored by
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Purpose
RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.
PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.
Condition / Treatment or Intervention / Phasebone metastases
Pain
unspecified adult solid tumor, protocol specific / Procedure:hyperthermia
Procedure:pain therapy
Procedure:radiofrequency ablation
Procedure:supportive care/therapy / Phase I
Phase II
Treatment for Peritoneal Carcinomatosis
This study is currently recruiting patients.
Sponsored by
National Cancer Institute (NCI)
Purpose
This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen):
- Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of chemotherapy; or
- Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after surgery.
Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests; chest x-ray and CT scans; review of pathology slides; EKG, bone scan, and brain MRI, as needed; and laparotomy. Laparotomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that the tumors cannot be removed will be taken off study. Those eligible for the study will have their tumors removed during this screening laparotomy as part of the study procedure, as follows:
All participants will undergo laparotomy and removal of as much tumor as possible, as described above. Patients will then be randomly assigned to one of two treatment groups:
- Group 1: During laparotomy, after tumor removal, patients receive continuous hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP, the cisplatin solution is heated and delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes and then drained out of the body through another catheter. At the close of surgery, a small catheter, called a Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter. The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital. Four to 6 weeks after the surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin a 4-month course of intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. The chemotherapy is given in four 4-week cycles as follows: oxaliplatin on day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and 2, infused over 2 hours, followed by 5-fluorouracil over 22 hours. This regimen is repeated 1 week later, followed by a 2-week break for completion of one cycle. Chemotherapy is given on an outpatient or inpatient basis, depending on the patient's comfort and side effects.