Fenretinide Lym-X-Sorb™ in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma

NCT ID: NCT00589381

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-03-31

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.

Detailed Description

OBJECTIVES:

Primary

• To determine the maximum tolerated dose of fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) in patients with recurrent and/or resistant solid tumors or lymphomas.
• To define the toxicities of 4-HPR/LXS oral powder in these patients.
• To determine the plasma pharmacokinetics of 4-HPR/LXS oral powder in these patients.

Secondary

• To determine the level of fenretinide delivered as 4-HPR/LXS oral powder in normal peripheral blood mononuclear cells.

OUTLINE: This is a multicenter study.

Patients receive oral fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) (mixed in food carriers) three times daily on days 1-7. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease response or better may receive additional courses of treatment at the discretion of the treating physician and principal investigator.

Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.

Conditions

Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fenretinide lipid matrix

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Shivaani Kummar, MD

Role: STUDY_CHAIR

NCI - Medical Oncology Branch

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21498721 (View on PubMed)

Other Identifiers

08-C-0030

Identifier Type: -

Identifier Source: secondary_id

NCI-P07187

Identifier Type: -

Identifier Source: secondary_id

CDR0000580777

Identifier Type: -

Identifier Source: secondary_id

080030

Identifier Type: -

Identifier Source: org_study_id