Clinical trial NCT00060684: Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma
Official title: A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Low-Grade
Lymphoma, Small Lymphocytic
Lymphoma, Mixed-Cell, Follicular
Lymphoma, Small Cleaved-Cell, Follicular
Keywords: Pixantrone
BBR 2778
chemotherapy
DNA Intercalator
mitoxantrone
fludarabine
dexamethasone
Rituximab
Rituxan
Mabthera
monoclonal antibody
antibody
NHL
Non-Hodgkin's lymphoma
indolent
low grade
Novuspharma
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2003-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.

Detailed description: The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.

This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.

Eligibility criteria: Inclusion criteria

* Patients with relapsed or refractory indolent (low-grade) NHL
* Who have received 1-3 prior treatments with chemotherapy

Exclusion criteria

* Patients previously treated with fludarabine
* Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment
* Patients known to have an allergic reaction to rituximab, or to murine proteins.

Primary outcomes:
measure: Determine MTD
timeFrame: Per cycle
Secondary outcomes:
measure: Establish safety profile
timeFrame: per cycle
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Albuquerque
country: United States
facility: New Mexico Onc/Hem Consultants, Inc.
state: New Mexico
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: CTI BioPharma
name: Scott Stromatt, MD
role: STUDY_DIRECTOR
References:
citation: Srokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.