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A Phase I-II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma, B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage II Adult Hodgkin Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Phase I-II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-cell Lymphoma


PRIMARY OBJECTIVES:

I. To evaluate the safety of fenretinide delivered in a 5 of 7 day regimen. (Phase I) II. To
estimate the efficacy (response rates) of fenretinide + rituximab in patients with B-cell
non-Hodgkin lymphoma (NHL). (Phase II)

SECONDARY OBJECTIVES:

I. To perform pharmacokinetic studies on patients receiving fenretinide. (Phase I) II. To
determine the intratumoral concentrations of fenretinide. (Phase I) III. To evaluate the in
vivo mechanism of action of fenretinide. (Phase I) IV. To identify the predictors of
response to fenretinide. (Phase I) V. To estimate the response rates, positron emission
tomography (PET) response, overall survival (OS), progression-free survival (PFS), time to
progression (TTP), and disease-free survival (DFS) of patients treated on this study. (Phase
I) VI. To estimate the overall survival (OS), progression-free survival (PFS), time to
progression (TTP), disease-free survival (DFS), and PET responses of patients treated on
this study. (Phase II) VII. To perform pharmacokinetic studies on patients receiving
fenretinide. (Phase II) VIII. To determine the intratumoral concentration of fenretinide.
(Phase II) IX. To identify the predictors of response to fenretinide and fenretinide +
rituximab in B-NHL. (Phase II) X. To evaluate the in vivo mechanism of action of fenretinide
in B-NHL. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of fenretinide followed by a phase II
study.

PHASE I: Patients receive fenretinide orally (PO) twice daily (BID) on days 1-5. Treatment
repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable
toxicity.

PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab
intravenously (IV) once weekly in weeks 5-8. Treatment continues in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.


Inclusion Criteria:



- Patients must have a confirmed cluster of differentiation (CD) 20+ lymphoid
malignancy

- All patients with indolent NHL (including Follicular, Marginal Zone, small
lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL),
lymphoplasmacytoid/Waldenström's, nodular lymphocyte predominant Hodgkins) are
potentially eligible

- Patients with Aggressive Lymphoma (including diffuse large B-cell, Burkitt's,
Burkitt's-like, B-lymphoblastic) may be considered for this protocol only if
unable or unwilling to receive potentially curative intensive therapy

- All Mantle Cell Lymphoma patients are potentially eligible

- The World Health Organization (WHO) classification of patient's malignancy must be
provided

- Patients must have a Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology
Group (ECOG) of =< 2

- Patients should have an expected survival if untreated of at least 60 days

- Patients must be expected to complete at least 8 weeks of therapy

- Serum bilirubin less than 2 times the upper limit of normal and no other serious
medical condition

- Creatinine less than 2 times the upper limit of normal and no other serious medical
condition

- Patients must have measurable disease defined as lesions that can be accurately
measured in two dimensions by computed tomography (CT), magnetic resonance imaging
(MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional
technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions
with both diameters >= 2 cm or evaluable disease in the bone marrow; patients must
have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with
evidence of adenopathy in the neck must have a CT of the neck; (Note: Patients with
CLL do not need to have radiographically measurable disease as this is not required
to measure response in this disease setting)

- All patients with an unknown prior bone marrow status or history of bone marrow
involvement must have a bone marrow aspirate and biopsy within 28 days of enrollment
and no intervening anticancer therapy

- All patients must be informed of the investigational nature of this study and have
given written consent in accordance with institutional and federal guidelines

Exclusion Criteria:

- Patients known to be human immunodeficiency virus (HIV) positive

- Patients with evidence of active central nervous system malignancy

- Pregnant or nursing women

- Men or women of reproductive potential may not participate unless they have agreed to
use an effective contraceptive method

- Concurrent anti-neoplastic therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, in terms of dose-limiting toxicity (DLT) of 2 daily doses of single agent fenretinide (Phase I)

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00104

NCT ID:

NCT00288067

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
  • B-cell Chronic Lymphocytic Leukemia
  • Contiguous Stage II Adult Burkitt Lymphoma
  • Contiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Contiguous Stage II Adult Lymphoblastic Lymphoma
  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Mantle Cell Lymphoma
  • Contiguous Stage II Marginal Zone Lymphoma
  • Contiguous Stage II Small Lymphocytic Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncontiguous Stage II Adult Burkitt Lymphoma
  • Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Noncontiguous Stage II Adult Lymphoblastic Lymphoma
  • Noncontiguous Stage II Grade 1 Follicular Lymphoma
  • Noncontiguous Stage II Grade 2 Follicular Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Marginal Zone Lymphoma
  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Splenic Marginal Zone Lymphoma
  • Stage I Adult Burkitt Lymphoma
  • Stage I Adult Diffuse Large Cell Lymphoma
  • Stage I Adult Hodgkin Lymphoma
  • Stage I Adult Lymphoblastic Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Stage I Grade 1 Follicular Lymphoma
  • Stage I Grade 2 Follicular Lymphoma
  • Stage I Small Lymphocytic Lymphoma
  • Stage II Adult Hodgkin Lymphoma
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Adult Burkitt Lymphoma
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage III Adult Hodgkin Lymphoma
  • Stage III Adult Lymphoblastic Lymphoma
  • Stage III Chronic Lymphocytic Leukemia
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage III Marginal Zone Lymphoma
  • Stage III Small Lymphocytic Lymphoma
  • Stage IV Adult Burkitt Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Hodgkin Lymphoma
  • Stage IV Adult Lymphoblastic Lymphoma
  • Stage IV Chronic Lymphocytic Leukemia
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Stage IV Marginal Zone Lymphoma
  • Stage IV Small Lymphocytic Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

University of Washington Medical CenterSeattle, Washington  98195-6043