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Lymphoma and Multiple Myeloma

Hodgkin Lymphoma

1

Disease Status and/or Stage Relapsed or Refractory Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma (Follicular, DLBCL, or Mantle Cell)
Protocol Title CALGB 50602: A Phase II Study of Galiximab (Anti-CD80) for Patients with Relapsed/Refractory Hodgkin Lymphoma
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Histologically confirmed diagnosis of classical Hodgkin's lymphoma. Patients must be relapsed or refractory after at least prior two systemic therapies.
Treatment Overview Therapy will consist of four weekly (induction) treatments followed by once monthy (extended induction) treatments of galiximab until disease progression. Thirty minutes prior to each galiximab infusion, premedication will include diphenhydramine 50 mg PO or IV and acetaminophen 650 mg PO. All patients will receive a minimum of 8 weeks of treatment with galiximab unless there is evidence of rapid disease progression sooner, either by phycial examination or radiographs.

2

Disease Status and/or Stage Untreated Hodgkin Lymphoma
Protocol Title Pilot study of abbreviated chemotherapy based on early positron emission tomography in Hodgkin lymphoma
PI Rebecca Elstrom , MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Patients must have histologically documented classical Hodgkin lymphoma. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma. Patients must have at least one hypermetabolic lesion identifiable on initial PET scan.

Treatment Overview

Patients will be treated with ABVD (Adriamycin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2 and dacarbazine 375 mg/m2) on Days 1 and 15 of each cycle
according to standard treatment guidelines.

Treatment cycles will be repeated every 28 days. Patients whose PET scans are negative after one cycle of treatment will receive two more cycles (total 3 cycles) of chemotherapy. Patients whose PET scans are positive
after one cycle of treatment will go off study and continue therapy as per their primary treating physician. Patients continuing on study will be evaluated for response after Cycle 1 and after completion of treatment.

3

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 June Greenberg, RN
212-746-2651
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.

4

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: March 30, 2009
© Weill Medical College of Cornell University
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