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Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma


OBJECTIVES:

- Determine the response rate and response duration in patients with cutaneous T-cell
lymphoma when treated with bexarotene and, in the absence of a complete response,
interferon alfa.

- Determine the safety and toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral bexarotene once daily for 8 weeks.

Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least
another 8 weeks in the absence of unacceptable toxicity.

Patients who progress or relapse during bexarotene therapy or who achieve less than a CR
after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral
bexarotene daily for at least another 8 weeks in the absence of continuing disease
progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cutaneous T-cell lymphoma

- Stage IB, IIA, IIB, III, or IV

- Measurable or assessable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 9 g/dL

- WBC at least 1,500/mm^3

- Platelet count at least 70,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT and SGPT no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 3 times ULN

- Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior
to study)

- No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any
other significant liver dysfunction)

Renal:

- Calcium no greater than 11.5 mg/dL

- Creatinine no greater than 2 times ULN

Cardiovascular:

- No myocardial infarction in the past 6 months

- No unstable angina

- No class III or IV congestive heart failure

- No ventricular tachyarrhythmias

Pulmonary:

- No pulmonary infiltrates or clinical pulmonary impairment

Other:

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception for 1 month before,
during, and for 1 month after study therapy

- No known allergy or sensitivity to interferon alfa or bexarotene or other components
of study drugs

- No uncontrolled thyroid disorder

- No other concurrent serious medical illness that would preclude study

- No infection

- No history of pancreatitis

- No history of neuropsychiatric disorders requiring hospitalization

- No history of autoimmune disease that would pose significant risk

- Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No concurrent systemic anticancer chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids

Radiotherapy:

- No concurrent localized radiotherapy to target lesions unless considered

- to have shown progressive disease

Surgery:

- Not specified

Other:

- At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin
A or any other retinoid class drug

- At least 30 days since prior participation in any other investigational drug study

- No concurrent systemic anti-psoriatic drugs or therapies

- No concurrent systemic other anticancer drugs or therapies

- No concurrent gemfibrozil

- No other concurrent investigational medication

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Straus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069202

NCT ID:

NCT00030849

Start Date:

October 2001

Completion Date:

December 2009

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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Abramson Cancer Center of the University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104-4283