Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00288067

Purpose

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fenretinide together with rituximab may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: fenretinide	Phase I Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Fenretinide Rituximab

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Maximum tolerated dose at 1 month [ Designated as safety issue: Yes ]
Response rate [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	February 2006
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Evaluate the safety of fenretinide in patients with B-cell non-Hodgkin's lymphoma. (phase I)
Estimate the efficacy (response rates) of fenretinide and rituximab in these patients. (phase II)

Secondary

Determine the response rates, positron emission tomography response, overall survival, progression-free survival, time to progression, and disease-free survival of these patients.
Determine the pharmacokinetics of fenretinide in these patients.
Determine the intratumoral concentration of fenretinide.
Evaluate the in vivo mechanism of action of fenretinide in these patients.
Identify the predictors of response to fenretinide and fenretinide plus rituximab in these patients.

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

Phase I: Patients receive oral fenretinide twice daily on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive oral fenretinide at the MTD twice daily on days 1-5. Treatment repeats weekly for at least 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 32, 39, 46, and 53 and then once every 3 months (after month 3) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Confirmed B-cell non-Hodgkin's lymphoma
- Confirmed CD20-positive disease
WHO classification of patient's malignancy must be provided
Measurable disease defined as lesions that can be accurately measured in 2 dimensions by CT scan, 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
- Radiographically measurable disease not required for chronic lymphocytic leukemia
Patients with evidence of adenopathy in the neck must have a CT scan of the neck
No evidence of active CNS malignancy

PATIENT CHARACTERISTICS:

SWOG/ECOG performance status ≤ 2
Expected survival (if untreated) of ≥ 60 days
Bilirubin < 2 times upper limit of normal (ULN)
Creatinine < 2 times ULN
No other serious condition
No known HIV positivity
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

At least 28 days since prior anticancer therapy
No other concurrent antineoplastic therapy
No concurrent ascorbic acid, vitamin A derivatives, vitamin E, or other antioxidants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288067

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ajay K. Gopal, MD

Seattle Cancer Care Alliance

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ajay K. Gopal, Seattle Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00288067 History of Changes
Other Study ID Numbers:	6071, P30CA015704, UWCC-6071, FHCRC-6071, NCI-6957, UWCC-UW-6071, UWCC-06-0644-H/A, CDR0000456502
Study First Received:	February 6, 2006
Last Updated:	June 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Fred Hutchinson Cancer Research Center:

extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic 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
splenic marginal zone lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma

stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 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 diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV grade 1 follicular lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Rituximab
Fenretinide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012