Clinical trial · Interventional
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
A Phase I-II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-cell Lymphoma
NCT00288067CI-TRIAL-00015780terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): NCI stopped supplying fenretinide in November of 2012.
Summary
Brief summary (as posted)
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 lymphoma. 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.
Conditions
Conditions (60)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma | Adult Nodular Lymphocyte Predominant B-Cell Lymphoma | ALIAS | 0.90 |
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Contiguous Stage II Adult Burkitt Lymphoma | — | UNRESOLVED | — |
| Contiguous Stage II Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Contiguous Stage II Adult Lymphoblastic Lymphoma | — | UNRESOLVED | — |
| Contiguous Stage II Grade 1 Follicular Lymphoma | — | UNRESOLVED | — |
| Contiguous Stage II Grade 2 Follicular Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (fenretinide, rituximab)
- description
- PHASE I: Patients receive fenretinide PO 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 IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: fenretinide
- Drug: rituximab
Primary outcomes (2)
- measure
- Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)
- timeFrame
- Number of participants that experienced a dose-limiting toxicity
- description
- A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.