Obatoclax and Bortezomib in Treating Patients With Aggressive Relapsed or Recurrent Non-Hodgkin Lymphoma

Stopped early · Phase 1

Conditions studied: Adult Non-Hodgkin Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT00538187

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2007-12-01

Last updated by the study team

2015-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Total bilirubin normal
• AST and ALT =< 2.5 times upper limit of normal
• Creatinine normal or creatinine clearance >= 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-barrier contraception during and for 3 months after the last dose of obatoclax mesylate
• At least 4 weeks since prior radiotherapy
• More than 2 days since prior steroids
• More than 2 weeks since prior low-dose chlorambucil
• WBC >= 3,000/mm\^3

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

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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