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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589381 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fenretinide lipid matrix |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase I Trial of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder (4-HPR/LXS Oral Powder) (4-HPR) in Adults With Solid Tumors and Lymphomas |
Estimated Enrollment: | 30 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed (by the NIH pathology department) diagnosis of 1 of the following:
No known brain metastases
PATIENT CHARACTERISTICS:
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
No clinically significant illnesses which could compromise participation in the study, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Patients must not take any drugs suspected of causing pseudo tumor cerebri, including any of the following:
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027-0700 | |
Contact: Barry J. Maurer, MD, PhD 323-361-5663 bmaurer@chla.usc.edu | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089 | |
Contact: Ann Mohrbacher, MD 323-865-3950 mohrbach@hsc.usc.edu | |
United States, Florida | |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Recruiting |
Fort Lauderdale, Florida, United States, 33308 | |
Contact: Martin Gutierrez, MD 954-267-7785 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000580777, NCI-08-C-0030, NCI-P07187 |
Study First Received: | December 20, 2007 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00589381 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia 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 adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent small lymphocytic lymphoma |
Anticarcinogenic Agents Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Leukemia Mycoses Cutaneous T-cell Lymphoma |
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Fenretinide Lymphoma, Large-cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Hodgkin Lymphoma, Adult Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy |
Anticarcinogenic Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Protective Agents |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Fenretinide Lymphoproliferative Disorders Lymphoma |