A Phase 2 interventional study of Targretin® (bexarotene) and pegylated liposomal doxorubicin hydrochloride in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 37 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma
Newly diagnosed or previously treated disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
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.
Drug: Targretin® (bexarotene) · Drug: pegylated liposomal doxorubicin hydrochloride
Median Progression-free Survival
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
Time frame: 3 years
Maximum Therapeutic Response
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
Time frame: 2 years
| Milestone | Doxil and Targretin® (Bexarotene) |
|---|---|
| Started | 37 |
| Completed | 37 |
| Not completed | 0 |
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
| months | Doxil and Targretin® (Bexarotene) |
|---|---|
| Median Progression-free Survival | 5 (0.16 to 26.26) |
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
| Participants | Doxil and Targretin® (Bexarotene) |
|---|---|
| Clinical Complete Response | 2 |
| Partial Response | 12 |
| Stable Disease | 6 |
| Progressive Disease | 14 |
| Not Evaluable | 3 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Doxil and Targretin® (Bexarotene) | 12/37 (32.4%) | 15/37 (40.5%) | 37/37 (100%) |
| Event | Doxil and Targretin® (Bexarotene) |
|---|---|
| Infection, otherInfections and infestations | 5/37 |
| Rigors/chillsGeneral disorders | 2/37 |
| Cardiac Arrhythmia, otherCardiac disorders | 1/37 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/37 |
| Death not assoc w CTCAE term-Disease prog NOSGeneral disorders | 1/37 |
| Fever (in the absence of neutropenia)General disorders | 1/37 |
| FractureInjury, poisoning and procedural complications | 1/37 |
| Gastritis (incl bile reflux gastritis)Gastrointestinal disorders | 1/37 |
| Inf norm ANC/gr1/2 neut-Cellulitis(skin)Infections and infestations | 1/37 |
| Inf unknown ANC-BloodInfections and infestations | 1/37 |
| Event | Doxil and Targretin® (Bexarotene) |
|---|---|
| HyperglycemiaMetabolism and nutrition disorders | 11/37 |
| White blood cellsInvestigations | 9/37 |
| Cholesterol, highInvestigations | 7/37 |
| Triglyceride, highMetabolism and nutrition disorders | 7/37 |
| FatigueGeneral disorders | 4/37 |
| NeutrophilsInvestigations | 4/37 |
| LymphopeniaInvestigations | 3/37 |
| Pruritus/itchingSkin and subcutaneous tissue disorders | 3/37 |
| Pain - BackMusculoskeletal and connective tissue disorders | 2/37 |
| Rash: hand-foot skin reactionSkin and subcutaneous tissue disorders | 2/37 |
| Age, Continuous(years) | Doxil and Targretin® (Bexarotene) |
|---|---|
| Median | 56 (27 to 81) |
| Sex: Female, Male(Participants) | Doxil and Targretin® (Bexarotene) |
|---|---|
| Female | 17 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Doxil and Targretin® (Bexarotene) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Doxil and Targretin® (Bexarotene) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Doxil and Targretin® (Bexarotene) |
|---|---|
| United States | 37 |
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Memorial Sloan Kettering Cancer Center