Phase 2 N=37 Treatment

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

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00255801 ↗

Enrolled (actual)

Serious AEs

40.5%

Results posted

Aug 2018

Primary outcome: Primary: Median Progression-free Survival — 5 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Targretin® (bexarotene) (Drug); pegylated liposomal doxorubicin hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Progression-free Survival	5	—
SECONDARY Maximum Therapeutic Response	2; 12; 6; 14; 3	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00255801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.