Lymphoma and Multiple Myeloma
Waldenstrom's Macroglobulinemia (WM)
1
| Disease Status and/or Stage | B-cell non-Hodgkin's lymphoma (including CLL/SLL and WM), multiple myeloma, or Castleman's Disease |
|---|---|
| Protocol Title | Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Administered Biweekly as an Intravenous Infusion in Subjects with Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease |
| PI | Richard Furman, MD |
| Contact | Patricia Glynn, RN 212-746-6738 |
| Key Eligibility | Patients with B-cell non-Hodgkin's lymphoma (including CLL/SLL and WM), multiple myeloma, or Castleman's Disease who have progressed on or after standard therapy. |
| Treatment Overview | Patients will receive Interleukin-6 at various times and doses depending on what cohort they are enrolled in. The maximum number of doses will be once weekly for 7 weeks. |
2
| Disease Status and/or Stage | Relapsed or Refractory Disease |
|---|---|
| Protocol Title | A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Lymphoid Malignancies |
| PI | Richard Furman, MD |
| Contact | Patricia Glynn, RN 212-746-6738 |
| Key Eligibility | Any relapsed or refractory lymphoma, excluding Burkett's lymphoma and patients who had a stem cell transplant. |
| Treatment Overview | Participants will self-administer ABT-263 by mouth once daily (QD). Each dose will be taken with approximately 240 mL of water. In Phase 1, all subjects will receive ABT-263 under fasting conditions on Cycle 1 Day -3 through Cycle 1 Day 1. On all other dosing days of Phase 1, the subjects will receive ABT-263 at approximately 30 minutes after breakfast. In Phase 2a, all subjects will self-administer ABT-263 at approximately 30 minutes after breakfast. The effect of food on pharmacokinetics will be evaluated and changes will be initiated if fasting conditions are superior. |
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 | 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. |
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. |
| 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). |
| Last updated: July 30, 2008 |  |
