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11 studies in Advanced Solid Tumors

  1. Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer Jacksonville, FL Rochester, MN View Summary
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    Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

    Location:

    Jacksonville, FL Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.

    NCT ID:

    NCT01010126

    IRB Number:

    08-005230

    Who can I contact for additional information about this study?

    Rochester: Charles Erlichman 507-284-2511
                        

    Jacksonville: Gerardo Colon-Otero 507-538-7623
                        

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  2. Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery Scottsdale and Phoenix, AZ View Summary
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    Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of cilengitide and paclitaxel at weekly dose schedule. II. To describe the toxicities associated with cilengitide and paclitaxel. III. To describe any antitumor activity of cilengitide and paclitaxel at weekly dose schedule. IV. To characterize pharmacokinetics (PK) of cilengitide and paclitaxel with the proposed schedule and correlate PK parameters to clinical outcome. V. To evaluate the effect of cilengitide and paclitaxel on circulating Cyr61 using a novel "sandwich ELISA" assay and to correlate this effect with clinical response. VI. To evaluate the information obtained through use of items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Phase I studies. OUTLINE: This is a dose-escalation study of cilengitide. Patients receive cilengitide intravenously (IV) over 1 hour on days* 1, 8, and 15 and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Some patients receive cilengitide IV over 1 hour on days 1, 2, 8, 9, 15, and 16. After completion of study treatment, patients are followed up for 3 months.

    NCT ID:

    NCT01276496

    IRB Number:

    10-006956

    Who can I contact for additional information about this study?

    Rochester: Julian R. Molina 507-284-2511
                        

    Jacksonville: Julian R. Molina
                        

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  3. Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas Rochester, MN View Summary
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    Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Ascenta Therapeutics, Inc. is conducting a clinical trial of the compound Debio 1143 (AT-406), a small molecule second mitochondria-derived activator of caspase C (Smac) mimetic. In vivo and in vitro studies have demonstrated that Debio 1143 (AT-406) induces cell death in several tumor models by inhibiting XIAP (X linked IAP), cIAP-1 (cellular IAP-1) and cIAP-2 (cellular IAP-2), thus releasing initiator and effector caspases to promote apoptosis. This protocol is a Phase I, dose-escalation, open-label, multi-center study conducted in patients with advanced solid tumors and lymphomas to evaluate the safety, tolerability and pharmacology of Debio 1143 (AT-406) in humans when administered orally.

    NCT ID:

    NCT01078649

    IRB Number:

    10-005788

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office 507-538-7623
                        


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  4. Dose Escalation Study to Determine Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 Scottsdale and Phoenix, AZ View Summary
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    Dose Escalation Study to Determine Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301

    Location:

    Scottsdale and Phoenix, AZ

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study will be a Phase I, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy.

    NCT ID:

    NCT01262235

    IRB Number:

    11-000470

    Who can I contact for additional information about this study?

    - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

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  5. Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of the combination of ABT-888 (veliparib) and weekly topotecan (topotecan hydrochloride) in adult patients with advanced solid tumors. (Phase I) II. To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors. (Phase I) III. To assess the confirmed response rate for patients with epithelial ovarian cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. IV. To assess the toxicity of the combination of ABT-888 and weekly topotecan in patients with epithelial ovarian cancer or primary peritoneal carcinoma. (Phase II) SECONDARY OBJECTIVES: I. To identify any pharmacokinetic interactions between ABT-888 and topotecan. (Phase I and II) II. Phase I MTD: to provide preliminary view as to difference in response and toxicity based on BRCA mutation status. (Phase I) III. To determine whether topotecan stimulates adenosine diphosphate (ADP)-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I) IV. To determine whether ABT-888 inhibits basal or topotecan-stimulated ADP-ribose polymer formation. (Phase I) V. To determine whether topotecan stimulates ADP-ribose polymer formation in circulating tumor cells and whether ABT-888 modulates this. (Phase II) VI. To assess differences in the toxicity and/or efficacy of this regimen based on BRCA 1/2 mutational status. (Phase II) VII. To determine whether pretreatment tumor cell levels of topoisomerase I, poly ADP-ribose polymerase (PARP), BRCA1, BRCA2, XRCC1, tyrosyl-deoxyribonucleic acid (DNA) phosphodiesterase 1 (TDP1), P-glycoprotein or breast cancer resistance protein (BCRP) predict response to this regimen. (Phase II) VIII. To identify, in an exploratory manner, any transcriptional profiles that may predict response to this regimen. (Phase II) OUTLINE: This is a phase I, dose escalation study of veliparib and topotecan hydrochloride followed by a phase II study. Patients receive veliparib orally (PO) on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride intravenously (IV) over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 months (Phase I) or every 3 or 6 months for 5 years (Phase II).

    NCT ID:

    NCT01012817

    IRB Number:

    09-000742

    Who can I contact for additional information about this study?

    Rochester: Charles Erlichman 507-538-7623
                        
    Scottsdale: Donald W. Northfelt 507-538-7623
                        

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  6. Cediranib Maleate and Selumetinib in Treating Patients With Solid Malignancies Scottsdale and Phoenix, AZ View Summary
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    Cediranib Maleate and Selumetinib in Treating Patients With Solid Malignancies

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. II. To describe the toxicity profile associated with AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. III. To describe the tumor responses and identify any activity of this AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. IV. To explore, through correlative studies, the effect of AZD2171 (cediranib) with or without AZD6244 hydrogen sulfate on serum markers of apoptosis. V. To assess the pharmacokinetic interaction of AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. VI. To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory study) results. OUTLINE: This is a dose-escalation study followed by a dose-expansion cohort study. Patients receive cediranib maleate orally (PO) once daily and selumetinib PO once or twice daily on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Some patients undergo blood sample collection at baseline and periodically during study for correlative studies. After completion of study therapy, patients are followed up at 3 months.

    NCT ID:

    NCT01364051

    IRB Number:

    11-001474

    Who can I contact for additional information about this study?

    Rochester: Paul Haluska 507-284-2511
                        

    Jacksonville: Paul Haluska 507-284-2511
                        

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  7. A Study of CDX-1127 in Patients With Select Solid Tumor Types or Hematologic Cancers Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    A Study of CDX-1127 in Patients With Select Solid Tumor Types or Hematologic Cancers

    Location:

    Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects. This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system. Eligible patients who enroll in the study will be assigned to one of 5 dose levels of CDX-1127. The first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies. During the second phase, up to 30 patients will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer. Patients enrolled in the study may receive study treatment for up to 5 cycles, until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

    NCT ID:

    NCT01460134

    IRB Number:

    11-005505

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Charanjit Singh, CRC 480-301-6046
                        

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  8. Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of the combination of vismodegib and sirolimus in unresectable solid tumors. (Cohort I) SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II. To describe the tumor responses to treatment combination. CORRELATIVE OBJECTIVES: I. To assess the effect of the sirolimus and vismodegib combination on selected biomarkers in tumor biopsies of patients with metastatic pancreatic cancer. II. To assess the effect of the combination of vismodegib and sirolimus on fludeoxyglucose F 18 (F18-FDG) positron emission tomography (PET) or PET/computed tomography (CT) imaging in Cohort II (MTD) patients with metastatic pancreatic cancer. III. To study the association of clinical (toxicity and/or tumor response or activity) with the biologic (pharmacodynamic) results obtained by examining tissue biopsies and PET or PET/CT imaging from the same patients. OUTLINE: This is a dose-escalation study of sirolimus. Patients receive sirolimus orally (PO) once daily (QD) and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months.

    NCT ID:

    NCT01537107

    IRB Number:

    11-005517

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  9. Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients With Advanced Cancers Scottsdale and Phoenix, AZ View Summary
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    Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients With Advanced Cancers

    Location:

    Scottsdale and Phoenix, AZ

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.

    NCT ID:

    NCT01563302

    IRB Number:

    12-001004

    Who can I contact for additional information about this study?

    - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

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  10. Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Rochester, MN View Summary
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    Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To establish the safety and tolerability of romidepsin given on days 1, 8, and 15 of a 28 day cycle to patients with varying degrees of liver dysfunction (mild, moderate and severe). II. To establish the maximum tolerated dose (MTD) and appropriate dosing recommendations for romidepsin in such patients. III. To characterize the pharmacokinetics (PK) of romidepsin in patients with varying degrees of liver dysfunction. SECONDARY OBJECTIVES: I. To explore correlations of the Child-Pugh classification of liver dysfunction with the observed toxicities and plasma PK of romidepsin administration. II. To document any preliminary evidence of antitumor activity at tolerable doses of romidepsin in patients with varying degrees of liver dysfunction. OUTLINE: This is a dose-escalation study. Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

    NCT ID:

    NCT01638533

    IRB Number:

    11-007228

    Who can I contact for additional information about this study?

    Rochester: Paul Haluska 507-284-2511
                        


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