NCT00538187

Brief Summary

Obatoclax may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Bortezomib and obatoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells. This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

December 4, 2015

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

October 1, 2007

Last Update Submit

December 3, 2015

Conditions

Adult Non-Hodgkin LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of obatoclax mesylate when administered with bortezomib

    Defined as the highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. Graded according to the NCI CTCAE, Version 3.0.

    35 days

Secondary Outcomes (2)

  • Toxicity as assessed by NCI CTCAE version 3.0

    Up to 26 weeks after completion of study treatment

  • Pharmacokinetics of obatoclax mesylate when administered with bortezomib

    Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours

Study Arms (1)

Treatment (obatoclax mesylate, bortezomib)

EXPERIMENTAL

Patients will receive a 3-hour infusion of obatoclax and an infusion of bortezomib once a week for 4 weeks

Drug: obatoclax mesylateDrug: bortezomibOther: laboratory biomarker analysisOther: pharmacological study

Interventions

obatoclax mesylateDRUG

Given IV

Also known as: GX15-070MS
Treatment (obatoclax mesylate, bortezomib)
bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (obatoclax mesylate, bortezomib)
laboratory biomarker analysisOTHER

correlative study

Treatment (obatoclax mesylate, bortezomib)
pharmacological studyOTHER

correlative study

Also known as: pharmacological studies
Treatment (obatoclax mesylate, bortezomib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed relapsed or refractory non-Hodgkin lymphoma for which standard curative or palliative measures do not exist or are no longer effective, including any of the following subtypes:
  • Follicular grade I, II, or III lymphoma
  • Marginal zone lymphoma
  • Mantle cell lymphoma
  • Diffuse large B cell lymphoma
  • Small lymphocytic lymphoma
  • Must have had at least one prior chemotherapeutic regimen:
  • Steroids or rituximab alone or local radiotherapy do not count as regimens
  • Tositumomab or ibritumomab tiuxetan allowed as regimens
  • Clear evidence of disease progression or lack of response after the most recent therapy, including rituximab or local radiotherapy, is required
  • At least 3 months since prior autologous stem cell transplantation and relapsed (\>= 1 year since prior allogeneic transplantation and relapsed) and no active related infections (i.e., fungal or viral)
  • In the case of allogeneic transplantation relapse, there should be no active acute graft-versus-host disease (GVHD) of any grade and no chronic GVHD other than mild skin, oral, or ocular GVHD not requiring systemic immunosuppression
  • No known active brain metastases, other neurological disorders/dysfunction or history of seizure disorder, or other neurological dysfunction
  • Karnofsky performance status 60-100%
  • Life expectancy \> 3 months
  • +13 more criteria

You may not qualify if:

  • Uncontrolled concurrent medical condition or illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia including QTc \> 450 msec
  • Patients who are intolerant or refractory to prior treatment with bortezomib (refractory is defined as no response to prior treatment with bortezomib)
  • Chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
  • Rituximab within the past 3 months (unless there is evidence of progression)
  • Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Other concurrent investigational agents
  • Combination antiretroviral therapy for HIV-positive patients
  • No history of allergic reactions attributed to bortezomib, polyethylene glycol (PEG 300), or polysorbate 20
  • No psychiatric illness or social situation that would limit compliance with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

obatoclaxBortezomib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph Tuscano

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

December 1, 2007

Primary Completion

April 1, 2011

Last Updated

December 4, 2015

Record last verified: 2013-05

Locations

US(1)