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Clinical Trial News Abstracts by Tom Swartz
[Editor's Note: Because the Clinical Trial News column is so highly accessed, we have reduced the need for you to "search" back issues of ESUN to locate clinical study information. We have created three separate webpages where all of the clinical trial information that we have published in ESUN to date has been collected. You can read about these changes in the editorial, Changes Made, in the October 2006 issue of ESUN. With the addition of the clinical trials described in this issue of ESUN, we now have over 195 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
This Phase I trial is currently recruiting patients. The majority of tumors are ignored by the immune system and it was thought for a long time that tumor antigens did not exist. However, recently a number of tumor antigens have been described. These antigens reside on cancer cells and can be recognized by specific T-cells which can ultimately attack and destroy the tumor. The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers. The trial is open to patients with advanced, refractory solid malignancies. The multi-component active immunotherapy, MKC1106-PP, consists of 1 plasmid dose and 2 peptides doses of sterile aqueous solutions designed to stimulate an immune reaction to two tumor associated antigens (PRAME and PSMA). A prime-boost treatment strategy will be employed wherein the plasmid component will be administered on Days 1, 4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into superficial inguinal lymph nodes under ultrasound guidance. Subjects will undergo immunologic evaluation on Day 39 of each treatment cycle, and will undergo an evaluation for extent of disease following every other treatment cycle. Subjects who do not have evidence of progressive neoplasia may remain in the clinical trial and receive up to 6 cycles of clinical trial treatment.
Two cohorts of subjects will be treated:
both cohorts will receive the same dose of plasmid. The total enrollment is 24 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, the District of Columbia, Florida, Nevada, and New Hampshire.
This Phase II trial is currently recruiting patients. This is a single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed. Patients 16 years of age and older are eligible. This trial is taking place in San Antonio, Texas.
Phase 2 Study in Patients With MiT Tumors This Phase II trial is currently recruiting patients. This is a multi-center, single arm, two-stage phase II study of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. ARQ 197 is a novel small molecule drug designed to block the activity of c-Met, which is thought to play multiple key roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The microphthalmia transcription factor tumors (MiT tumors) are clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS), and translocation associated renal cell carcinoma (RCC). These soft tissue cancers are characterized by a common transcriptional mechanism that leads to inexorable spread and resistance to all known therapies. They tend to strike adolescents and young adults, and are invariably fatal if not resectable at diagnosis. Several academic laboratories have shown that genetic translocations in these tumors upregulate c-Met, and that such tumors are dependent upon this activity.
The study will enroll adolescent (age 13 or older) and adult patients with a histologically or cytologically confirmed MiT malignant disease. Eligible patients will receive ARQ 197 twice daily. Treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. During the study, tumor evaluations will be performed at baseline, then in 8-week intervals. To evaluate each patient's safety and the drug's toxicity, physical examinations, laboratory evaluations, vitals signs, and adverse event assessments will be performed throughout the study. Blood samples for PK analysis will be collected during first cycle of treatment from up to 10 patients aged 20 or younger. Archival tissue specimens and relevant laboratory results on patients' gene translocation/fusion status will be collected. Tumor biopsies may also be collected (optional) with patient's consent. If patients agree tumor samples may be collected using core needle biopsy. In addition, to explore biological responses of tumors to ARQ 197 treatment, FDG-PET scanning will be performed at three time points: within 14 days prior to the treatment, on Day 8 (± 2 days) of Cycle 1 and after two cycles of treatment coinciding with tumor measurement. The total enrollment will be 45 patients. This trial is taking place at Premiere Oncology, Santa Monica, California, Dana Farber Cancer Institute (not yet recruiting), Boston, Massachusetts, Texas Children's Cancer Center (not yet recruiting) Houston, Texas, and Mary Crowley Cancer Research Center (not yet recruiting) Dallas, Texas.
Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies This Phase I trial is currently recruiting patients. The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib. This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers. The trial is open to patients with solid cancer for which curative measures have failed or for which there is no known superior treatment. The total enrollment is 24 patients. Patients 18 years of age and older are eligible. This trial is taking place at the University of Chicago, Chicago, Illinois.
Phase 1 Study With Sorafenib and Sirolimus This Phase I trial is currently recruiting patients. The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials. The trial is open to patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus. Patients 18 years of age and older are eligible. This trial is taking place at Radboud University, Nijmegen, Netherlands.
Study on VCD/IE in the Patients With ESFT (Ewing's Sarcoma Family of Tumors) This Phase II trial is currently recruiting patients. The purpose of this clinical trial is to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with Ewing’s Sarcoma Family of Tumors. This trial is taking place at Fudan University Cancer Hospital, Shanghai, China. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage. The total enrollment is 30 patients. Patients between 10 and 65 years of age are eligible.
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine This Phase I/II trial is currently recruiting patients. MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase (HDAC) inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice, two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease. MGCDo103 has never been combined with gemcitabine. Studies in the laboratory have shown that treatment with a drug like MGCDo103 may make cancer cells more sensitive to treatment with a drug like gemcitabine when the two drugs are given as part of the same treatment. The Phase I portion of the trial is open to patients with refractory solid tumors. The Primary Outcome Measures of the study are:
The total expected enrollment is 60 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Indiana, North Carolina, Ohio, Pennsylvania, and Tennessee.
A Study of Apomab in Patients With Advanced Chondrosarcoma This Phase II trial is currently recruiting patients. Apomab is being developed by Genentech. Apomab is a fully human monoclonal antibody which is a DR5-targeted pro-apoptotic receptor agonist (PARA) specifically designed to induce apoptosis. Apoptosis is a natural process by which damaged or unwanted cells, including those that are cancerous, die and are cleared from the body. Pro-apoptotic receptor DR5 is expressed in a broad range of malignancies. This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of Apomab when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled. Patients 18 years of age and older are eligible. This trial is taking place at the Sarcoma Oncology Center, Santa Monica, California, and the Dana Farber Cancer Institute, Boston, Massachusetts.
Not Yet Recruiting Patients (not previously published in ESUN)
This Phase I trial is net yet open for recruiting patients. Monoclonal antibodies, such as R1507, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. This phase I trial is studying the side effects and best dose of monoclonal antibody R1507 in treating young patients with recurrent or refractory advanced solid tumors. Patients receive anti-IGF-1 receptor human monoclonal antibody R1507 (R1507) IV over 60-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Archival tumor tissue from original biopsy or surgical pathology specimens is obtained at baseline for pharmacodynamic studies. Tissue samples are examined by immunohistochemistry for biomarker proteins related to R1507 activity in insulin-like growth factor-1 receptor (IGF-1R)-signaling pathways. Blood specimens are obtained at baseline and periodically during study for pharmacokinetic and pharmacodynamic studies. Blood specimens are examined for IGF-1R-signaling biomarker proteins and changes in IGF-1R -signaling patterns after treatment with R1507. Blood specimens are also examined for human-anti-human antibodies and lymphocyte subsets. Positron emission tomography scans using the tracer, fluorine-18 (F-18) fluorodeoxyglucose (FDG), are performed at baseline and after the week 2 dose to assess the early effects of R1507 on metabolic activity in tumor tissue. After completion of study therapy, patients are followed at day 30. The total enrollment is 32 patients. Patients 2 to 17 years of age are eligible. The locations of this trial have not yet been identified.
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