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| ID | Type | Description | Link |
|---|---|---|---|
| 08-C-0030 | |||
| NCI-P07187 | |||
| CDR0000580777 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorbâ„¢ , 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-Sorbâ„¢ in treating patients with recurrent or resistant solid tumors or lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral fenretinide Lym-X-Sorbâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenretinide lipid matrix | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of 4-HPR/LXS oral powder | ||
| Safety | ||
| Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Level of fenretinide in normal peripheral blood mononuclear cells |
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DISEASE CHARACTERISTICS:
Histologically confirmed (by the NIH pathology department) diagnosis of 1 of the following:
Recurrent and/or resistant disease
Measurable or evaluable disease
No known brain metastases
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
No clinically significant illnesses which could compromise participation in the study, including, but not limited to, any of the following:
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:
No concurrent herbal supplements or other alternative therapy medications
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| Name | Affiliation | Role |
|---|---|---|
| Shivaani Kummar, MD | NCI - Medical Oncology Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| USC/Norris Comprehensive Cancer Center and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21498721 | Result | 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. |
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| Los Angeles |
| California |
| 90089 |
| United States |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D016399 | Lymphoma, T-Cell |
| D000072281 | Lymphadenopathy |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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