Clinical Trials

9 studies in Lymphoma, Hodgkin Disease, Adult

1. Collecting and Storing Biological Samples From Young Patients With Hodgkin's Lymphoma Rochester, MN View Summary
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   Collecting and Storing Biological Samples From Young Patients With Hodgkin's Lymphoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - Establish a biologic specimen repository (of tumor tissue, tissue arrays, lymphoblastoid cell lines, host DNA, tumor and host RNA, serum, and plasma) and database linked to clinical features and outcomes from well-characterized cohorts of children and young adults with Hodgkin's lymphoma. - Provide specimens from diagnosis, early response evaluation, completion of chemotherapy and radiotherapy, long-term follow up, and relapse to study prognostic factors for early response, relapse, long-term outcomes, and identification of new biological targets for therapy. OUTLINE: This is a multicenter study. Patients enrolled on Hodgkin's lymphoma (HL) therapeutic clinical trials undergo collection of tumor tissue samples at baseline and at relapse or disease progression. Serum and anticoagulated peripheral blood samples are collected at baseline, at week 1, on day 1 of course 2, after completion of chemotherapy, after completion of radiotherapy, at 1 year after diagnosis, and at relapse or disease progression. Patients with relapsed or progressive disease who plan to enroll on HL relapse/retrieval clinical trials undergo collection of tumor tissue, serum, and anticoagulated peripheral blood samples at relapse or disease progression. Patients enrolled more than 1 year after completion of treatment undergo collection of tumor specimens, serum, and anticoagulated peripheral blood samples at time of clinical evaluation. PROJECTED ACCRUAL: A total of 1,272 patients will be accrued for this study.

   NCT ID:

   NCT00900250

   IRB Number:

   07-007701

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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2. Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma Rochester, MN View Summary
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   Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) of LBH589 and RAD001 when used in combination in patients with myeloma or lymphoma (Phase I). II. Arm A: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory lymphoma. (Phase II) III. Arm B: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory multiple myeloma (Phase II) SECONDARY OBJECTIVES: I. To further describe the toxicities associated with the combination of LBH589 with RAD001 in each arm independently. II. To evaluate overall survival, progression-free survival, and duration of response in each arm independently. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetic interaction of LBH589 and RAD001. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat and oral everolimus once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed periodically for 2 years.

   NCT ID:

   NCT00918333

   IRB Number:

   08-004746

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   Who can I contact for additional information about this study?

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

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3. Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose of RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase I) II. To assess tumor response to RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase II) SECONDARY OBJECTIVES: I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving RAD001 and lenalidomide. II. To describe the adverse event profile (using CTCAE CTEP Active Version) of RAD001 and lenalidomide. OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

   NCT ID:

   NCT01075321

   IRB Number:

   09-003801

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   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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4. 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

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office 507-538-7623
                       
   
   
   

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5. 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

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   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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6. Induction Chemotherapy w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma Rochester, MN View Summary
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   Induction Chemotherapy w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study is designed as a single arm pilot feasibility trial using an induction of 2-6 cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients with stage I and II non-bulky Hodgkin Lymphoma (HL). Feasibility will be determined by the percentage of patients who have no clinical evidence of HL, and achieve PET negative disease post brentuximab consolidation. We anticipate approximately 20 patients will be eligible across participating centers (including UNC, Mayo Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year period. A future phase II study evaluating progression free survival (PFS) after ABVD followed by brentuximab vedotin will be considered feasible if ≥ 13 of 15 patients enrolled in this pilot trial become PET negative after brentuximab vedotin consolidation.

   NCT ID:

   NCT01578967

   IRB Number:

   12-006953

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   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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7. Safety Study of Anti-Programmed Death-1 in Hematologic Malignancy Rochester, MN View Summary
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   Safety Study of Anti-Programmed Death-1 in Hematologic Malignancy

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to determine the side effects of treatment with the monoclonal antibody anti-PD-1 (BMS-936558) in subjects with relapsed/refractory hematologic malignancy and the dose that should be recommended for use in future studies.

   NCT ID:

   NCT01592370

   IRB Number:

   12-004166

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   Who can I contact for additional information about this study?

   Rochester: Stephen Ansell, Site 002 507-284-0923
                       
   
   
   

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8. Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma Rochester, MN View Summary
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   Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To evaluate the progression-free survival (PFS) at 36 months following registration for patients who are positron emission tomography (PET) negative after 2 courses of chemotherapy, and receive 4 additional courses of doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) followed by involved-nodal radiotherapy [INRT] of 30-30.6 Gy. Secondary - To evaluate the PET-negative rate after 2 courses of ABVD chemotherapy in patients with stage I/II Hodgkin lymphoma with bulky mediastinal disease. - To evaluate the PFS at 36 months for patients who are PET positive after 2 courses of chemotherapy and receive 4 courses of escalated bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, procarbazine hydrochloride, and prednisone (BEACOPP) followed by INRT of 30-30.6 Gy. - To evaluate the complete response (CR) rate and overall survival (OS) for PET-positive and PET-negative patients after 2 courses of ABVD. - To identify sites of relapse following combined-modality therapy (CMT) for patients with large mediastinal adenopathy and correlate with RT fields. - To assess toxicity on both arms of study. - To assess reproductive function at baseline and at 3 years after ABVD or escalated BEACOPP with specific serum markers. - To bank serum and plasma at baseline and selected time points to assess the prognostic value of various markers such as, but not limited to, SCD30, IL10, CCL17, CCL22, and MDC. - To create tissue microarrays (TMAs) from patient tumor blocks for future biomarker assessment including, but not limited to, bcl-2, FOXP3, and macrophage content. - To measure serum TARC levels pre-treatment and post two courses of ABVD and correlate with PET-CT findings (performed at same time points) and 3 year PFS. Tertiary - To assess the predictive value of fludeoxyglucose F 18 (18FDG) uptake, as measured by semi-quantitative measurements including standard uptake variables (SUVs), with respect to response at the end of chemotherapy and PFS. - To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with CT size change information. - To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with available serum and tissue molecular biomarkers. - To compare the results of the secondary imaging objectives with the corresponding CALGB 50801 results (contingent on reaching agreement with CALGB on the combined analysis of the two studies). OUTLINE: This is a multicenter study. Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are then assigned to an intervention arm according to fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT) results (negative vs positive). - ABVD (18FDG-PET/CT negative): Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. - Escalated or standard BEACOPP* (18FDG-PET/CT positive): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. NOTE: *HIV-positive patients whose 18FDG-PET/CT scans are positive after two courses of induction ABVD receive 4 courses of standard BEACOPP followed by INRT. Patients undergo 18FDG-PET scans at baseline, and within 8-10 days after 2 courses of ABVD induction chemotherapy. Patients also undergo 18FDG-PET/CT** scan within 3-8 weeks after completion of 4 courses of BEACOPP and 6 courses of ABVD, and 3 months after completion of INRT. NOTE: **If PET/CT remains positive, then a biopsy may be performed if medically appropriate or clinically feasible at the discretion of the treating physician. If biopsy is positive, patients will be followed for survival and secondary malignancies or new primaries. Patients may undergo blood sample collection for correlative studies. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.

   NCT ID:

   NCT01390584

   IRB Number:

   12-005771

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9. Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma Rochester, MN View Summary
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   Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

   NCT ID:

   NCT01712490

   IRB Number:

   12-006385

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