NCT00255801 · CITED IN SOURCE DOCUMENTS

Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-08-16

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Progression-free Survival

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outcome · POSTED

Maximum Therapeutic Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous T-cell lymphoma * Stage IB-IV disease * Measurable disease * Newly diagnosed or previously treated disease * No demonstrated resistance to prior bexarotene PATIENT CHARACTERISTICS: Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram * No New York Heart Association class II-IV heart disease * No clinical evidence of congestive heart failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No history of hypersensitivity reactions attributed to doxorubicin HCl liposome or its components * No active potentially life-threatening infection * No other acute disease PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics * Prior doxorubicin allowed provided the cumulative dose is ≤ 300 mg/m\^2 * Prior epirubicin hydrochloride allowed provided the cumulative dose is ≤ 540 mg/m\^2
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: Targretin® (bexarotene)
Drug: pegylated liposomal doxorubicin hydrochloride
label
Doxil and Targretin® (bexarotene)
type
EXPERIMENTAL

interventions

arm Group Labels
Doxil and Targretin® (bexarotene)
name
Targretin® (bexarotene)
type
DRUG
arm Group Labels
Doxil and Targretin® (bexarotene)
name
pegylated liposomal doxorubicin hydrochloride
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 37
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
Median Progression-free Survival
time Frame
3 years

secondary Outcomes

description
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
measure
Maximum Therapeutic Response
time Frame
2 years

Full study description

brief Summary: 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.
detailed Description: OBJECTIVES: Primary * Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell lymphoma treated with doxorubicin HCl liposome followed by bexarotene. Secondary * Determine the complete and partial response rate in patients treated with this regimen. 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.

Source references

references

citation
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.
pmid
24285015
type
DERIVED