Clinical trial NCT00039156: BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
Official title: An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: recurrent grade 3 follicular 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 Burkitt lymphoma
recurrent mantle cell lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862.
* Determine the overall survival in patients treated with this drug.
* Determine the time to progression in patients treated with this drug.
* Determine the duration of response (CR and PR) in patients treated with this drug.
* Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
* Determine the pharmacokinetic profile of this drug in selected patients.

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 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:

* See Disease Characteristics
* At least 4 weeks since prior anticancer chemotherapy
* No more than 3 prior systemic chemotherapy regimens for metastatic NHL:

  * High-dose therapy for autologous hematopoietic stem cell transplantation (SCT) is considered 1 prior regimen
  * Salvage chemotherapy followed by autologous bone marrow transplant or peripheral SCT is considered 1 prior regimen
  * Antibody treatment is not considered 1 prior regimen
* No prior taxanes or oxaliplatin
* No other concurrent anticancer chemotherapy

Endocrine therapy:

* Patients with prior parenchymal or meningeal CNS involvement:

  * No concurrent acute or tapered steroid therapy
  * Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Shreveport
country: United States
facility: Veterans Affairs Medical Center - Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Shreveport
state: Louisiana
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Clinical Cancer Center
state: New York
city: Brooklyn
country: United States
facility: HemOnCare, P.C.
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital - Vancouver
state: British Columbia
Study officials:
affiliation: Montefiore Medical Center
name: Rasim Ahmet Gucalp, MD
role: STUDY_CHAIR
References: