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Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year progression-free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David J. Straus, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-098

NCT ID:

NCT00255801

Start Date:

November 2005

Completion Date:

September 2013

Related Keywords:

  • Lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009