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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-05098 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Tibotec Pharmaceutical Limited | INDUSTRY |
| M.D. Anderson Cancer Center | OTHER |
| NYU Langone Health |
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.
PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by bexarotene works in treating patients with cutaneous T-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks. Patients who achieve a complete or partial response may continue to receive bexarotene in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxil and Targretin® (bexarotene) | Experimental | Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targretin® (bexarotene) | Drug |
| ||
| pegylated liposomal doxorubicin hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Therapeutic Response | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
|
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DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma
Measurable disease
Newly diagnosed or previously treated disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| David J. Straus, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Steven M. Horwitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Patricia L. Myskowski, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States | ||
| Roswell Park Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24285015 | Derived | Straus DJ, Duvic M, Horwitz SM, Hymes K, Goy A, Hernandez-Ilizaliturri FJ, Feldman T, Wegner B, Myskowski PL. Final results of phase II trial of doxorubicin HCl liposome injection followed by bexarotene in advanced cutaneous T-cell lymphoma. Ann Oncol. 2014 Jan;25(1):206-10. doi: 10.1093/annonc/mdt480. Epub 2013 Nov 26. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxil and Targretin® (Bexarotene) | Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2008 |
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| OTHER |
| Hackensack Meridian Health | OTHER |
| Roswell Park Cancer Institute | OTHER |
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| Drug |
|
| 2 years |
| Buffalo |
| New York |
| 14263-0001 |
| United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxil and Targretin® (Bexarotene) | Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Progression-free Survival | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
| Posted | Median | Full Range | months | 3 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Therapeutic Response | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
| Posted | Count of Participants | Participants | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxil and Targretin® (Bexarotene) | Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse. | 12 | 37 | 15 | 37 | 37 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia, other | Cardiac disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastritis (incl bile reflux gastritis) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Blood | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Leukocytes (total WBC) | Investigations | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Pain - Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain - Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pneumonitis/pulm infiltrates | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rigors/chills | General disorders | Systematic Assessment |
| ||
| Ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| White blood cells | Investigations | Systematic Assessment |
| ||
| Cholesterol, high | Investigations | Systematic Assessment |
| ||
| Triglyceride, high | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Neutrophils | Investigations | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain - Back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Straus | Memorial Sloan Kettering Cancer Center | 212-639-8365 | strausd@mskcc.org |
| Mar 16, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| 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 |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|