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Lymphoma and Multiple Myeloma

Hodgkin's Disease (HD)

1

Disease Status and/or Stage Relapsed or Refractory Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma (Follicular, DLBCL, or Mantle Cell)
Protocol Title A Phase 2, Open-label Trial to Evaluate the Efficacy and Safety of MGCD0103 Administered in Combination With Azacitidine (VidazaŽ) to Subjects With Relapsed or Refractory Hodgkin's or Non-Hodgkin's Lymphoma, and to Evaluate the Pharmacokinetics of Different Formulations of MGCD0103 (103 PH US 2007 CL002)
PI Rebecca Elstrom, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Histologically confirmed diagnosis of classical Hodgkin's lymphoma or NHL (follicular lymphoma, DLBCL, or MCL) and confirmed relapsed or refractory disease
Treatment Overview In Part I, all patients will receive two doses of MGCD0103 over a 2 week period and blood drawn for pharmacokinetic studies. In Part II, patients will receive azacitidine on days 1-5 of a 28 day cycle followed by MGCD0103 on days 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 of each 28-day cycle.

2

Disease Status and/or Stage Relapsed or Refractory Hematologic Malignancies
Protocol Title A Phase I Dose Escalation Study of SGN-35 in Patients with Relapsed/refractory CD30 Positive Hematologic Malignancies
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility

Adult subjects with histologically confirmed CD30-positive hematologic malignancy and have failed systemic chemotherapy as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy and refused or were ineligible for stem cell transplant.
Treatment Overview

SGN-35 will be administered on Day 1 of each 21 day cycle via a 2-hour intravenous infusion according to the dose level assigned to each cohort.

3

Disease Status and/or Stage Any Stage of Cancer
Protocol Title Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis
Treatment Overview

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)
  Last updated: July 30, 2008
© Weill Medical College of Cornell University
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