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Clinical Trials Currently Accepting Eligible Patients
This Phase II trial is currently recruiting patients. SCH 717454 is a fully human antibody directed against the insulin-like growth factor 1 receptor (IGF-1R), which is implicated in the growth and metastatic phenotype of a broad range of malignancies.
In this study, Subjects with resectable osteosarcoma will be randomized to one of two dose levels of SCH 717454 to be given intravenously. These subjects will first receive SCH 717454 according to randomized treatment, and have surgery performed at a defined time after initial dosing. Subjects will be allowed to recover from surgery prior to additional SCH 717454 administration at their randomized dose level. SCH 717454 will then be administered on the same calendar day once every 2 weeks. Subjects will continue to receive SCH 717454 until disease recurrence, or until completing a year of dosing at the same dose level assigned, whichever occurs first.
Subjects with unresectable osteosarcoma or Ewing's sarcoma will be assigned treatment to SCH 717454 IV administered once every two weeks and will continue to receive SCH 717454 until disease progression.
The estimate enrollment is 90 patients. Patients 11 years of age and older are eligible. This trial is taking place at centers in Delaware, New York, and Texas.
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma This Phase I trial is currently recruiting patients. Bortezomib may enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly. Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance). Weekly administration of the combination will be given at various levels as follows:
Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
The estimated enrollment is 40 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Massey Cancer Center of Virginia Commonwealth University, Richmond, Virginia.
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types This Phase II trial is currently recruiting patients. The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from Brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to Brivanib. Patients will receive Brivanib by oral tablets, 800 mg, once daily, until progression. The estimated enrollment is 400 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Illinois, Maryland, Nevada, New York, Pennsylvania, Belgium, Canada, France, Germany, Netherlands, Poland, and the United Kingdom.
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain This Phase III trial is currently recruiting patients. Pain from bone metastases is the most common cause of cancer pain. As more patients are living with bone metastases, improving their quality of life becomes a major challenge. Current treatments for patients with bone metastases are primarily palliative. Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. While external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, many patients do not experience pain relief. The ExAblate system is designed to non-invasively ablate tissue. It thus may meet the need of these EBRT failed patients. The palliative effect of ExAblate is achieved by heating the bone periosteum, thus ablating the sensory origin of the pain. Thus, the purpose of this study is to evaluate the effectiveness and safety of ExAblate treatment of metastatic bone tumors for the palliation of pain in patients who are not candidates for radiation therapy. The estimated enrollment is 148 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Massachusetts, New York, Pennsylvania, Texas, Canada, and Israel.
A Study of R7112 in Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of R7112, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity. The estimated enrollment is 70 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Colorado, New York, and Texas.
A Phase I Study of BIIB015 in Relapsed/Refractory, Cripto-Positive Solid Tumors This Phase I trial is currently recruiting patients. This is an open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors. The drug BIIB015 will be given by IV infusion once every 3 weeks until disease progression or unacceptable toxicity. The estimated enrollment is 55 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California and Texas.
Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors This Phase I trial is currently recruiting patients. ASONEP™ (sonepcizumab/LT1009) is a humanized monoclonal antibody that possesses anti-angiogenic and anti-tumor activity in animal models of human cancer. ASONEP™ binds sphingosine 1-phosphate (S1P), a bioactive lipid signaling molecule that possesses potent pro-growth effects. Preclinical studies with ASONEP™ (sonepcizumab/LT1009) and LT1002 (murine homolog of LT1009), demonstrate the potential of an anti-S1P treatment to reduce tumor volumes and metastatic potential, likely as a result of inhibiting new blood vessel formation needed to support tumor growth. The purpose of this study is to determine the safety, tolerability and highest dose of ASONEP that can safely be administered to patients with solid tumors who are no longer being helped by standard treatments. ASONEP [sonepcizumab/LT1009] is supplied as a colorless,particulate-free, pH 6.5, sterile solution containing approximately 10 mg/mL or 20 mg/mL of drug. The candidate drug is intended for single intravenous (iv) use administered over 90 minutes on a weekly basis. The estimated enrollment is 37 patients. Patients 18 years and older are eligible. This trial is taking place at centers in Arizona and California.
Study of TRC102 in Combination With Pemetrexed in Cancer Patients (102ST101) This Phase I trial is currently recruiting patients. This study is being performed to evaluate the safety and tolerability of TRC102 in combination with Alimta in patients with advanced or metastatic solid cancer for whom curative therapy is unavailable. In addition to safety, this study will also evaluate pharmacokinetics and tumor response. The estimated enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arizona, California, and Ohio
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors This Phase I trial is currently recruiting patients. Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is studying the side effects and best dose of nelfinavir in treating patients with metastatic, refractory, or recurrent solid tumors. This is a dose-escalation study. Patients receive oral nelfinavir mesylate twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue to receive nelfinavir mesylate. Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients receive oral midazolam hydrochloride on days -2 and 20 and then undergo blood collection on days -2 and 20 for midazolam pharmacokinetics to determine CYP3A4 activity. Nelfinavir mesylate pharmacokinetics are performed on day 1 of courses 1 and 2. Patients also undergo blood collection on days 1, 8, and 42 for biological marker laboratory studies, including vascular endothelial growth factor and basic fibroblast growth factor levels as measured by enzyme-linked immunosorbent assay and phospho-Akt, total Akt, cleaved Parp, Beclin 1, p-eIF2α, LC-3, and other signal transduction markers as measured by Western blot. A total of 45 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland.
Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors This Phase I trial is currently recruiting patients. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. This trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. This is a multicenter study.
Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined.
Blood samples are collected prior to treatment on day 1 of courses 1, 2, and 5 or 6 for pharmacokinetic studies. After completion of study treatment, patients are followed for at least 30 days. The estimated enrollment is 27 patients. Patients between 1 and 21 years of age are eligible. This trial is taking place at centers in Alabama, California, Illinois, Indiana, Ohio, Tennessee, Texas, and Washington.
A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen This Phase I trial is currently recruiting patients. This is a phase 1, open label, multiple dosing, single arm study. Each patient will be enrolled to receive MBV subcutaneously at the starting dose of 250 EU (1 µL) twice weekly. In the absence of a dose-limiting toxicity (DLT, the MBV dose will be escalated in each patient to the MBV dose level that elicits a body temperature of 38C -39.5C or up to the maximum dose level 8. Once the desired pyrogenic effect is reached, patients will then be given MBV twice weekly for 4 doses at the pyrogenic dose level. For patients not achieving the desired pyrogenic effect at dose level 8, no additional MBV will be administered. Vaccination will be administered twice weekly on Monday and Thursday of each week.
During each vaccination clinic visit, patients will be observed up to 6 hours post vaccination and vital signs will be measured hourly. At baseline, and throughout the study period, patients will be assessed for NY-ESO-1 specific humoral and cellular immunity, chemistry, hematology and cytokine analysis for IL-1, IL-6, IFNgamma, and TNF-alpha. Toxicity assessments will be made throughout the study. The estimated enrollment is 12 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Ludwig Institute for Cancer Research, Frankfurt, Germany.
ABT-888, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer This Phase I trial is currently recruiting patients. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with carboplatin and paclitaxel may help kill more tumor cells. This trial is studying the side effects and best dose of ABT-888 when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer. Patients receive escalating doses of oral ABT-888 twice daily on days 1-7 (beginning in course 2) in combination with carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 3. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Peripheral blood mononuclear cells are collected on day 1 of course 1 and days 1 and 3 of course 2 for pharmacokinetic studies, evaluation of DNA adducts, and Poly-ADP ribose (PAR) levels. After completion of study treatment, patients are followed for 4 weeks. The estimated enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California and Pennsylvania.
A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent This Phase II trial is currently recruiting patients. This multicenter, open-label, study will enroll approximately 185 patients with metastatic or advanced sarcoma, to assess the efficacy and tolerability of IMC-A12 monotherapy. The patient population will be stratified into five tiers according to diagnosis: Ewing's sarcoma/PNET; rhabdomyosarcoma; leiomyosarcoma; adipocytic sarcoma; synovial sarcoma. A total of 85 patients will be enrolled initially, 17 in each tier. Patients will receive single agent IMC-A12 as a 10 mg/kg intravenous (I.V.) infusion over 1 hour every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation every cycle. The Simon two-stage design will be applied separately to each tier; safety and response in the initial 17 patients in each tier will be used to determine whether to extend enrollment to the target total of 37 patients per tier (for a total of 185 subjects). Patients 12 years of age and older are eligible. This trial is taking place at MD Anderson Cancer Center Orlando, Florida.
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas This Phase II trial is currently recruiting patients. The purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas. Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment. A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated. The estimated enrollment is 30 patients. Patients up to 30 years of age are eligible. This trial is taking place at Massachusetts General Hospital and Dana-Farber Cancer Institute, Boston Massachusetts.
AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. This is a multicenter study. Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks. The estimated enrollment is 37 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Fox Chase Cancer Center, Philadelphia, Pennsylvania, and at centers in Canada.
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors This Phase I trial is currently recruiting patients. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. This trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors. This is a dose-escalation, multicenter study.
Patients receive fenretinide IV continuously on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients undergo blood sample collection to determine plasma concentrations (pharmacokinetics) of fenretinide periodically during course 1 and at the end of courses 2-6. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. A total of 21 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in California.
This Phase I trial is currently recruiting patients. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. This trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. This is a multicenter study. Patients are stratified according to disease (refractory solid tumors [stratum 1] vs. Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) [stratum 2 - accrual to this stratum will be restricted to patients ≥ 12 years of age until safety is determined in stratum 1; then accrual will continue for patients of all ages]). Patients receive IMC-A12 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for up to 2 years in the absence of unacceptable toxicity or disease progression. Patients undergo blood sample collection periodically for pharmacokinetic, immunogenicity, and other correlative studies. Samples are analyzed for serum levels of IGF-I, IGF-II, IGF-BP3, growth hormone, insulin, and C-peptide; trough concentrations and PK sampling; and biomarkers, including IGF-IR expression and phosphorylation and insulin receptor expression and phosphorylation via immunoprecipitation and Western immunoblotting. Tumor tissue samples from patients with Ewing sarcoma/peripheral PNET are banked for future research. After completion of study treatment, patients are followed at 30 days. The estimated enrollment is 48 patients. Patients between 1 and 21 years of age are eligible. This trial is taking place at centers in Alabama, California, the District of Columbia, Missouri, Ohio, Oregon, and Texas.
This Phase I trial is currently recruiting patients. Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic acidosis and rare metabolic disorders in humans. Further testing now shows that it may suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of the body have found that it killed lung, breast, and brain cancer cells, without affecting human normal cells. Tumors in rats that were infected with human tumors also shrank considerably. Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal cells) that makes them more likely to grow as well as be resistant to most cancer treatments. Plus, many current cancer treatments kill both cancerous and healthy cells and are highly toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells, thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of the cancer cells. This mitochondrial reactivation presents an entirely new approach to treating cancer. DCA is known to be relatively well tolerated with few significant side effects and its selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It is hoped that one day this treatment may become a safe and effective treatment, either along or in conjunction with other treatments, for many forms of cancer. The purpose of this trial is to (1) assess safety and tolerability of oral DCA; (2) determine the dose-limiting toxicity and phase II dose; and (3) characterize DCA’s pharmacokinetic profile. It is open to patients with histologically or cytologically confirmed recurrent or metastatic solid tumors with no meaningful therapies available. Patients 18 years of age and older are eligible. This trial is taking place at the Cross Cancer Institute, Edmonton, Canada.
LBH589, Paclitaxel, Carboplatin +/- Bevacizumab for Solid Tumors This Phase I trial is currently recruiting patients. This trial will evaluate the safety and tolerability of the combination of LBH589 and paclitaxel/carboplatin in patients with solid tumors. The combination of LBH589, paclitaxel/carboplatin, and bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a subset of patients with advanced non-small cell lung cancer.
The estimated enrollment is 40 patients. Patients 18 years of age and older are eligible. This trial is taking place at Tennessee Oncology, PLLC, Nashville, Tennessee.
LBH589 and Gemcitabine in the Treatment of Solid Tumors This Phase I trial is currently recruiting patients. This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation. The estimated enrollment is 40 patients. Patients 18 years of age and older are eligible. This trial is taking place at Tennessee Oncology, PLLC, Nashville, Tennessee.
A Study of R1507 in Patients With Recurrent or Refractory Sarcoma This Phase II trial is currently recruiting patients. R1507 is a human monoclonal antibody designed to inhibit (turn off) tumor growth. This single arm study will evaluate the efficacy and safety of R1507 in patients with recurrent or refractory sarcoma. Five cohorts of sarcoma patients will be studied in parallel: Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, and other sarcomas. All patients will receive R1507 9mg/kg by IV weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, and the target sample size is 100-500 individuals. Patients 12 years of age and older are eligible. This trial is taking place at 62 locations worldwide (not all currently recruiting).
R1507 in Patients With Recurrent or Refractory Sarcomas This Phase II trial is currently recruiting patients. R1507 is a human monoclonal antibody designed to inhibit (turn off) tumor growth. The primary objectives of this trial are to: (1) determine the overall objective response rate of R1507 in patients with recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas of the following subtypes: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma; and (2) determine the progression-free survival at 18 weeks from start of treatment of patients with progressive, recurrent or refractory Ewing's sarcoma. Patients will receive 9 mg/kg of R1507 by IV weekly Over 60 Minutes. The estimated enrollment is 245 patients. Patients 12 years of age and older are eligible. This trial is taking place at centers in Washington, D.C., Michigan, Pennsylvania, Texas, France, and the United Kingdom.
This Phase II trial is not yet recruiting patients. This study will assess the safety and efficacy of a combination of Avastin and standard chemotherapy, compared with standard chemotherapy alone, in childhood and adolescent patients with metastatic rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) or Ewing's sarcoma/soft tissue primitive neuroectodermal tumors (ET/PNET). Patients will be randomized to receive Avastin + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy, +/- Avastin 7.5mg IV on day 1 of each cycle) followed by 4-week cycles of maintenance treatment (standard chemotherapy, +/- Avastin 5mg/kg IV on days 1 and 15 of each cycle). A safety analysis will be carried out after the first 44 patients have completed 6 cycles of treatment, before further patients are recruited. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Patients between 2 and 17 years of age are eligible. This trial will take place at centers in France, Italy, the Netherlands, and the United Kingdom.
This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as vincristine, topotecan, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop tumor growth by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. This randomized phase II trial is studying giving vincristine together with topotecan, and cyclophosphamide to see how well it works compared with giving vincristine together with topotecan, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma. Patients are stratified according to time to disease recurrence (< 2 years vs. ≥ 2 years).
After completion of study therapy, patients are followed periodically. The estimate enrollment is 78 patients. Patients between 1 and 29 years of age are eligible. This trial is taking place at the Stanford Cancer Center, Stanford, California, the Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut, Farmington, Connecticut, Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio.
This Phase I/II trial is currently recruiting patients. This multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma. The estimated enrollment is 90 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Massachusetts, Pennsylvania, Austria, Belgium, France, and the Netherlands.
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