NCT00589381

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 lymphoma

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

December 20, 2007

Last Update Submit

March 7, 2012

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent adult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenström macroglobulinemiarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose of 4-HPR/LXS oral powder

  • Safety

  • Toxicity

Secondary Outcomes (1)

  • Level of fenretinide in normal peripheral blood mononuclear cells

Interventions

fenretinide lipid matrixDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed (by the NIH pathology department) diagnosis of 1 of the following: * Solid tumor malignancy that is metastatic or unresectable * Lymphoma for which standard treatment or curative measures do not exist, or are associated with minimal patient survival benefit * Recurrent and/or resistant disease * Measurable or evaluable disease * No known brain metastases * Patients whose brain metastatic disease status has remained stable for ≥ 3 months after treatment may be eligible at the discretion of the principal investigator (without steroids or anti-seizure medications) PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/µL * Platelets ≥ 100,000/µL (CTCAE v.3 grade 1 thrombocytopenia allowed if explained by involvement of the bone marrow by lymphoma) * Total bilirubin ≤ 1.5 times normal institutional limits (2.5 mg/dL for patients with Gilbert's syndrome) * AST (SGOT)/ALT (SGPT) ≤ 2.5 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use two methods of birth control, including at least one highly effective method (e.g., intrauterine device \[IUD\], hormonal birth control pills/injections/implants, tubal ligation or partner's vasectomy), and one additional effective method (e.g., latex condoms, diaphragm, or cervical cap), prior to, during, and for 2 months after completion of study treatment * Men must use a latex condom every time they have sexual intercourse during therapy and for 2 months after discontinuing fenretinide, even if they have had a successful vasectomy * No clinically significant illnesses which could compromise participation in the study, including, but not limited to, any of the following: * Active or uncontrolled infection * Immune deficiencies or confirmed diagnosis of HIV infection * Uncontrolled diabetes * Uncontrolled hypertension * Symptomatic congestive heart failure * Unstable angina pectoris * Myocardial infarction within the past 6 months * Uncontrolled cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * No known wheat gluten allergy or allergy or sensitivity to the study drug * No history of pancreatitis as evidenced by elevated amylase or lipase ≥ grade 2 and accompanied by symptoms of pancreatitis (e.g., abdominal pain) PRIOR CONCURRENT THERAPY: * Recovered from adverse events and/or toxicity due to prior chemotherapy or biologic therapy * No chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas, mitomycin C, or UCN-01) * At least 1 month since any prior radiotherapy or major surgery * At least 2 weeks since any prior administration of study drug in an exploratory IND/phase 0 study * Patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy * No concurrent sulfonamides * No other concurrent investigational agents * No other concurrent cancer chemotherapy, or immunomodulating agents (including systemic corticosteroids) * Patients must not take any drugs suspected of causing pseudo tumor cerebri, including any of the following: * Tetracycline * Nalidixic acid * Nitrofurantoin * Phenytoin * Sulfonamides * Lithium * Amiodarone * Vitamin A (except as part of routine total parenteral nutrition vitamin supplements or in a single daily standard dose oral multivitamin supplement) * No concurrent herbal supplements or other alternative therapy medications

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Childrens Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Kummar S, Gutierrez ME, Maurer BJ, Reynolds CP, Kang M, Singh H, Crandon S, Murgo AJ, Doroshow JH. Phase I trial of fenretinide lym-x-sorb oral powder in adults with solid tumors and lymphomas. Anticancer Res. 2011 Mar;31(3):961-6.

    PMID: 21498721RESULT

MeSH Terms

Conditions

LymphomaHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shivaani Kummar, MD

    NCI - Medical Oncology Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 9, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(4)