Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Sarcoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Germ Cells Tumors

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Cyclophosphamide

Vaccines

Immunomodulating Agents

Celecoxib

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

autologous tumor vaccine plus chemotherapy

5x 10\^7 autologous tumor cells emulsified in 0.5 mL ISCOMATRIX adjuvant will be administered IM every 4 weeks for 6 months

Epigenetically Modified Autologous Tumor

50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each 4 week treatment cycle

400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each 4 week vaccine cycle.

David S Schrump, M.D.

Background:

- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a patient and then used to develop a vaccine. The vaccine will produce an immune system response to help destroy other cancer cells in the body. Researchers are studying ways to improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been used safely in other clinical studies. But it has not been studied with certain tumor cell vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth after tumor removal surgery.

Objectives:

- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and drug therapy after tumor removal surgery.

Eligibility:

- People at least 18 years of age who have had tumor cell vaccines developed from cells taken from surgically removed tumors.

Design:

* Patients will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
* Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily) for 7 days before the first vaccine dose.
* Patients will receive the tumor cell vaccine once a month for 6 months. They will continue to receive drug therapy throughout the vaccine treatment. Patients will be monitored with regular blood tests and imaging studies.
* After the first 6 months, patients who have an immune response to the vaccine will continue treatment with the vaccine and chemotherapy. They will also have regular blood tests and imaging studies. They will have this treatment for up to 24 months from the first vaccination or until they no longer have an immune response.
* Participants will have followup visits for up to 5 years after the first vaccination, or until the tumor returns.

Background:

Cancer-testis (CT) antigens (CTAs) have emerged as attractive targets for cancer immunotherapy. Whereas cancers of various histologies exhibit CTA expression, primary or vaccine-induced immune responses to these antigens appear uncommon in patients with these malignancies, possibly due to low-level, heterogeneous antigen expression, and inadequate vaccination strategies. Because numerous CT antigens can be induced in tumor cells by DNA demethylating agents and HDAC inhibitors, it is conceivable that vaccination of cancer patients with autologous tumor cells exposed to chromatin remodeling agents will enhance anti-tumor immunity in these individuals. In order to examine this issue, patients undergoing complete resection of sarcomas, melanomas, germ cell tumors and epithelial malignancies metastatic to the lungs, pleura or mediastinum will be vaccinated with autologous tumor cells exposed ex-vivo to decitabine and radiation following completion of appropriate combined modality therapy. Vaccines will be administered in conjunction with ISCOMATRIX adjuvant as well as metronomic oral cyclophosphamide (50 mg PO BID x 7d q 14d), and celecoxib (400 mg PO BID). Serologic responses to a variety of recombinant CTAs as well as delayed type hypersensitivity to autologous epigenetically modified tumor cells will be assessed before and after vaccination.

Primary Objective:

-To assess the safety of an epigenetically modified autologous tumor cell vaccine administered with ISCOMATRIX adjuvant in combination with metronomic oral cyclophosphamide and celecoxib in patients undergoing thoracic metastasectomy.

Eligibility:

* Patients with histologically or cytologically proven or clinically evident sarcoma, melanoma, or epithelial malignancies metastatic to lungs, pleura or mediastinum who can be rendered no evidence of disease (NED) by metastasectomy.
* Patients must be 18 years or older with an ECOG performance status of 0 2, without evidence of unstable or decompensated myocardial disease. Patients must have adequate pulmonary reserve evidenced by FEV1 and DLCO equal to or greater than 30% predicted; pCO2 less than 50 mm Hg and pO2 greater than 60 mm Hg on room air ABG; and be on no immunosuppressive medications except inhaled corticosteroids at the time vaccination commences.
* Patients must have a platelet count greater than 100,000, an ANC equal to or greater than 1500 without transfusion or cytokine support, a normal PT, and adequate hepatic function as evidenced by a total bilirubin of \<1.5 x upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2) at the time vaccination commences.

Design:

* Patients will undergo thoracic metastasectomy using standard of practice guidelines.
* Portions of the resected tumors will be transferred to the Thoracic Oncology Laboratory. Cells will be processed to establish a cancer cell line.
* Following recovery from surgery and appropriate adjuvant chemotherapy and/or radiation, patients will be vaccinated with epigenetically-modified autologous tumor cells periodically over 6 months in conjunction with metronomic oral cyclophosphamide and celecoxib.
* Systemic toxicities and delayed type hypersensitivity responses to autologous tumor cells and serologic responses to a variety of CT antigens will be assessed before and after vaccination.
* Patients will be followed with routine staging scans until disease recurrence.
* As the exact set of comparisons and analyses to be performed will be determined following completion of the trial, and will be based on limited numbers of patients, the analyses will be considered exploratory and hypothesis generating rather than definitive.
* Approximately 80 patients will be accrued to this trial in order to obtain up to 20 evaluable patients.

Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal

Epigenetically-Modified Autologous Tumor Cell Vaccs and ISCOMATRIX(TM) Adjuvant With Metronomic Oral Cyclophosphamide and Celecoxib in Pts Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura or Mediastinum

National Cancer Institute (NCI)

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

Central Nervous System Depressants

Dermatologic Agents

Ether

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Photosensitizing Agents

Patients receive porfimer sodium IV over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative photodynamic therapy to the pleural space.

porfimer sodium

Undergo tumor resection and/or radical pleurectomy

therapeutic conventional surgery

photodynamic therapy

Meng Welliver

This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.

PRIMARY OBJECTIVES; I. To determine the feasibility and toxicities of incorporating surgical resection and intra-operative Photofrin (porfimer sodium)-mediated photodynamic therapy in patients (pts) with malignant pleural mesothelioma (MPM) or non-small cell lung cancer (NSCLC) with pleural spread.

SECONDARY OBJECTIVES:

I. To determine the overall survival rate of pts with NSCLC and pleural spread treated with standard frontline chemotherapy followed by surgical resection and intra-operative Photofrin-mediated photodynamic therapy.

II. To determine the overall survival rate of pts with MPM after radical pleurectomy and intraoperative Photofrin-mediated photodynamic therapy (PDT).

III. To determine the progression-free survival and pleural progression-free survival in the above mentioned pts.

IV. To determine the absolute Photofrin levels in tumor and normal tissues resected from pts using spectrofluorometric assay. Photofrin levels in tumor to normal tissue ratios will be determined.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative PDT to the pleural space.

After completion of treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy

All observed toxicities will be graded, tabled and summarized by frequencies and percentages.

Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Estimated by the method of Kaplan and Meier. PPFS will be estimated for the subset of patients who receive PDT, in order to evaluate the impact of PDT on local control. Survival curves will be plotted. Median and 1-year estimates and confidence intervals will be calculated.

Porfimer sodium concentration in the tissue will be calculated based on the increase in fluorescence resulting from the addition of a known amount of porfimer sodium to each sample after its initial reading. Absolute concentrations of porfimer sodium will also be measured. Distribution of uptake will be summarized by mean, median, standard deviation, range, and histogram. The tumor: normal tissue ratio from direct and indirect measurements will be calculated. Spearman's correlation will be employed to correlate and compare direct and indirect measurements.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Pleural Effusion

Pleural Effusion, Malignant

Cancer Pain

Pain

Pleural Diseases

Ibuprofen

Morphine

Opiate Alkaloids

Analgesics, Opioid

Narcotics

Chest tube greater than 14 French size and ibuprofen.

Large bore chest drain + NSAID based analgesic regimen

Chest tube less than or equal to 14 French size and ibuprofen.

Small bore chest drain + NSAID based analgesic regimen

Chest tube greater than 14 French size and morphine.

Large bore chest drain + opiate based analgesic regimen

Chest tube less than or equal to 14 French size and morphine.

Small bore chest drain + opiate based analgesic regimen

RJO Davies, Dr.

Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.

The investigators hope to find the best way to prevent pain during pleurodesis.

Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. Talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. This procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. Reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure.

This trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. It will also address whether either of these influences success rate of pleurodesis.

We hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. We hope to find the best way of preventing pain during this procedure.

The First Therapeutic Intervention in Malignant Pleural Effusion Trial

TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.

University of California, Davis

(PDT) Photodynamic therapy

Keith Cengel, MD

The primary objective of the study is to determine the maximally tolerated photodynamic therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with pleural malignancy who have undergone a maximal resection.

Photodynamic therapy (PDT) is an experimental treatment that uses a drug called a photosensitizer or photosensitizing agent and light to kill cells. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills hearby cells. The appeal o PDT in oncology has been that the photosensitizer is retained in tumor tissue for longer periods of time compared to normal tissues. This reported differential of photosensitizer retention in tumor compared to normal tissues provides the potential for an enhanced therapeutic index minimizing normal tissue toxicity has prompted an interest in studying PDT as a cancer treatment and is a proposed treatment for a variety of malignancies and pre-malignant conditions. The proposed study is a Phase I trial of photodynamic therapy (PDT) for the treatment of patients with pleural malignancies. To participate patients must be 18 years of age or older, must have a histological diagnosis of pleural malignancy, must have disease limited to the hemithorax (one side of the chest), must be medically suitable for resection, and must have a ECOG performance status of 0-2. Patients who have received prior surgery, gene therapy, or combination chemotherapy will also be permitted if it has been at least 30 days since the last treatment. Patients will be given HPPH, by intravenous injection prior to surgery. HPPH is a chlorine based photosensitizer used along with PDT to prevent recurrence of tumors following surgical removal. After successful tumor removal light from a tunable dye laser or diode laser will be administered. The starting dose of PDT will ve administered 24 or 48 hours prior to surgical resection. Red light will be used to illuminate the entire thoracic cavity. If adequate removal of the tumor cannot be performed , the patient will not be eligible to receive light therapy. In parallel laboratory studies, biopsies of tumor and normal tissues will be taken from the resection specimens. Uptake of HPPH will be measured in tumor and normal tissues and tumor to normal tissue ratios of HPPH will be determined. Assessment of molecular signaling including EGFR, Akt, and MAPK will be made in tumor prior to and after light delivery. Patients will simultaneously be enrolled on a companion protocol in which the 2-nitroimidazole, EF5 will be administered to determine tumor oxygen concentration. Finally, non-invasive measurements of optical properties, tissue oxygenation, photosensitizer uptake, and blood flow will be made intraoperatively. After hospital discharge patients will be seen routinely in outpatient Thoracic Surgery and Radiation Oncology Department clinics. These follow visits will occur one month., two months later and every three months of the first 24 months to assess treatment related toxicities. A history and physical examination, laboratory and a CT or MRI of the chest will be performed every 3 months. A follow-up chest x-ray will be obtained as clinically indicated. An assessment of toxicity will be made at each follow-up visit. After 24 months, follow-up should be scheduled as clinically indicated.

HPPH and PDT for Pleural Malignancy

A Phase 1 Trial of Photodynamic Therapy With HPPH in Patients With Pleural Malignancy

Abramson Cancer Center at Penn Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal	NCT01341496	Sarcoma Melanoma Epithelial Mali... Pleural Maligna...	Epigenetically ... Cyclophosphamid... Celecoxib	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal	NCT01341496	Sarcoma Melanoma Epithelial Mali... Pleural Maligna...	Epigenetically ... Cyclophosphamid... Celecoxib	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy	NCT02106559	Stage III Malig... Stage IIIB Non-... Stage IV Malign... Stage IV Non-sm...	porfimer sodium therapeutic con... photodynamic th...	18 Years -	Ohio State University Comprehensive Cancer Center
The First Therapeutic Intervention in Malignant Pleural Effusion Trial	NCT00896285	Malignant Pleur... Pleural Effusio...	Large bore ches... Small bore ches... Large bore ches... Small bore ches...	18 Years -	University of California, Davis
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy	NCT02106559	Stage III Malig... Stage IIIB Non-... Stage IV Malign... Stage IV Non-sm...	porfimer sodium therapeutic con... photodynamic th...	18 Years -	Ohio State University Comprehensive Cancer Center
HPPH and PDT for Pleural Malignancy	NCT01673074	Pleural Maligna...	(PDT) Photodyna...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for pleural malignancy