Clinical Trial: BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

This study has been suspended.

Sponsored by: Theradex
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent grade III follicular large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent mantle cell lymphoma
 Drug: BAY 59-8862
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter, open-label study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
  • Diffuse large B-cell lymphoma
  • Transformed NHL
  • Follicular large cell lymphoma
  • Peripheral T cell lymphoma
  • Anaplastic large cell lymphoma
  • Mantle cell lymphoma
  • Unclassified aggressive histology
  • Immunoblastic lymphoma
  • Failed at least 1 prior therapy (primary resistant) OR
  • Previously achieved a remission and then progressed or relapsed within 6 months of therapy
  • At least 1 bidimensionally measurable lesion
  • Lesions within a previously irradiated field are not considered measurable
  • No relapse within 6 months after prior autologous bone marrow transplantation
  • No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder
  • No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
  • PT, INR, and PTT less than 1.5 times ULN
  • No chronic hepatitis B or C

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No clinically evident congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No serious cardiac arrhythmias
  • No active coronary artery disease or ischemia

Other:

  • No prior hypersensitivity to taxane compounds
  • No known or suspected allergy to the investigational study agent or any agent given in association with this study
  • No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied)
  • No substance abuse or medical, psychological, or social conditions that would preclude study participation
  • No active clinically serious infections
  • No other condition that is unstable or would preclude study participation
  • No grade 2 or greater pre-existing peripheral neuropathy
  • No history of seizure disorder
  • Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 4 weeks since prior anticancer immunotherapy
  • At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
  • No concurrent anticancer immunotherapy
  • No concurrent prophylactic G-CSF
  • Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed
  • Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months prior to study

Chemotherapy:

Endocrine therapy:

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • Concurrent palliative radiotherapy allowed provided:
  • No progressive disease
  • No more than 10% of bone marrow is irradiated
  • Radiation field does not encompass a target lesion
  • No other concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • At least 4 weeks since prior investigational drugs
  • No other concurrent investigational therapy or approved anticancer therapy
  • No concurrent illicit drugs or other substances that would preclude study
  • Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT
  • Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints
  • Concurrent bisphosphonates for prophylaxis or bone metastases allowed

Location Information


Florida
      Mount Sinai Comprehensive Cancer Center, Miami Beach,  Florida,  33140,  United States

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101,  United States

New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08903,  United States

New York
      Albert Einstein Clinical Cancer Center, Bronx,  New York,  10461,  United States

      HemOnCare, P.C., Brooklyn,  New York,  11235,  United States

      New York Medical College, Valhalla,  New York,  10595,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

Tennessee
      West Clinic, Memphis,  Tennessee,  38120,  United States

Washington
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109,  United States

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226-3596,  United States

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Canada, British Columbia
      St. Paul's Hospital - Vancouver, Vancouver,  British Columbia,  V6Z 1Y6,  Canada

Study chairs or principal investigators

Rasim Ahmet Gucalp, MD,  Study Chair,  Montefiore Medical Center   

More Information

Study ID Numbers:  CDR0000069358; THERADEX-100389; BAYER-100389; SUNY-HSC-4553
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039156
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005