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A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Hodgkin's Disease

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Trial Information

A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma


Inclusion Criteria:

Phase 1: Patients with evaluable or measurable (by MRI or CT)
Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable
Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must
be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil
or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive
NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior
treatment with Rituximab and who are not candidates for high-dose chemotherapy or
autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem
cell transplant recipients are eligible if 100 days have elapsed since procedure.
Exclusion Criteria: Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These
patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL,
except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage
prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to
and/or receipt of treatments contraindicated by administration of G-CSF - Patients with
active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding
females. - Previous treatment with a KSP inhibitor

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: Determination of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) first without and then with administration of prophylactic G-CSF.

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Owen O'Connor, M.D./Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

CY 2121

NCT ID:

NCT00343564

Start Date:

April 2006

Completion Date:

July 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Hackensack University Medical CenterHackensack, New Jersey  07601
University of North CarolinaChapel Hill, North Carolina  27599
Cornell University Medical CenterNew York, New York  10021
Memorial Sloan-Kettering Caner CenterNew York, New York  10021
Sarah Cannon Cancer Research InstituteNashville, Tennessee  37203