Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
Brief Summary: RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides

  * Stage IB or IIA
  * Confirmed by current or prior diagnostic lesion biopsy

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 2,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN

Renal

* Creatinine no greater than 2 times ULN
* Calcium no greater than 11.5 mg/dL

Cardiovascular

* No New York Heart Association grade III or IV cardiac insufficiency

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation\* NOTE: \*Women using hormonal contraception must also use a non-hormonal treatment
* Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization)
* Willing and able to avoid prolonged exposure to the sun

  * Willing to limit sun exposure on day of PUVA therapy
* No prior intolerance of or unresponsiveness to PUVA therapy
* No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No prior pancreatitis
* No other concurrent serious illness or infection that would preclude study participation
* No concurrent excessive alcohol consumption
* No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No known contraindications to study drug
* No known hypersensitivity to retinoids or hypervitaminosis A
* No uncontrolled diabetes mellitus
* No uncontrolled thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 3 months since prior interferon therapy

Chemotherapy

* No prior systemic combination chemotherapy
* No prior participation in another study of bexarotene
* At least 3 months since prior topical chemotherapy

Endocrine therapy

* At least 1 month since prior topical corticosteroids

Radiotherapy

* At least 6 months since prior total skin electron beam therapy
* At least 1 month since prior superficial radiotherapy

Surgery

* Not specified

Other

* At least 30 days since prior participation in another investigational drug study
* At least 3 months since prior photopheresis
* At least 1 month since prior UVB/PUVA phototherapy
* At least 1 month since prior retinoid class drugs
* At least 1 month since prior beta-carotene compounds
* At least 1 month since other prior topical medications (e.g., tar baths)
* No prior participation in this study
* No other concurrent anticancer therapy
* No other concurrent investigational drug therapy
* No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations
B: DISEASE CHARACTERISTICS:

* Diagnoses of advanced T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome

  * Stage IIB-IV disease
* Achieved complete or partial response after undergoing prior debulking therapy with 1 of the following recommended\* regimens with or without radiotherapy\*\*:

  * Gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 of a 28-day course at a dose of 1,000 to 1,200 mg/m² for a total of four courses
  * Pegylated liposomal doxorubicin hydrochloride IV over 1 hour on days 1 and 15 of a 28-day course at a dose of 20 mg/m² for a total of four courses NOTE: \*These recommended regimens can be altered according to local institutional policies. In case of drug intolerance, the study regimen can be switched from one regimen to the other.

NOTE: \*\*Local low-dose/energy-ionizing radiation therapy allowed as part of the debulking process to treat lesions that do not respond after 3 courses of debulking chemotherapy.

* Sézary cell burden must be decreased by at least 50% after debulking in patients with Sézary syndrome
* Disease not appropriate for skin-directed therapy per local institution standards
* No disease progression between registration and randomization
* No CNS involvement

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 12 months
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 60 x 10\^9/L
* Total bilirubin ≤ 1.5 times upper limit of normal (UNL)
* Alkaline phosphatase ≤ 3 times UNL
* ALT/AST ≤ 3 times UNL
* Electrolytes (including sodium, potassium, and chloride) normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* Uric acid and calcium normal
* Free T4 and TSH ≤ 1.5 times ULN
* Patients with a buffer range from the normal values of +/- 10% for hematology and biochemistry are acceptable
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 4 weeks prior to, during, and for 4 weeks after completion of study therapy
* Males must agree not to donate semen during and for 1 week after completion of study therapy
* Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anticoagulation therapy (e.g., vitamin K) to keep INR in the range of 2-3
* No New York Heart Association class III-IV disease
* No blood donating during and for 1 week after completion of study therapy
* No uncontrolled infectious disease, autoimmune disease, or immunodeficiency
* No second malignancies within the past 3 years except surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal or squamous cell carcinoma of the skin
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* No Lapp lactase deficiency or history of glucose-galactose malabsorption

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other prior intravenous chemotherapy for this cancer

  * For purposes of this protocol, the definition of intravenous chemotherapy also includes denileukin diftitox, antibodies, or antibody conjugates
* No prior splenectomy or splenic irradiation
* No concurrent topical corticosteroids

  * Concurrent systemic corticosteroids allowed for treatment of tumor flare reactions
* No radiation or drug-based therapy (including steroids) between registration and randomization
* No other concurrent drugs (including steroids) during the debulking regimen

  * Low-dose steroids as premedication allowed at the investigator's discretion
* No other concurrent anticancer treatments
C: Inclusion Criteria:

* Patients with mycosis fungoides confirmed by a skin biopsy
* Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)
* Patients must be otherwise healthy with acceptable organ function.
* Prior to initiating study therapy, patients must not have had topical therapy within four weeks
* Lab values within normal range
* Willing/able to give consent
* Must use effective means of contraception if of childbearing potential

Exclusion Criteria:

* Newly diagnosed mycosis fungoides with no prior therapy
* A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)
* Use of topical or systemic therapies for MF within four (4) weeks of entry in the study
* Patients with a diagnosis of stage IIB-IV MF
* Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program
* Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
* Patients who have had radiation therapy within one year of study start
* Patients who have a history of a higher T score than T2 or a higher N score than N1
* Patients who do not agree to do all labs at one site
D: Inclusion Criteria:

* Voluntary consent form
* Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
* Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapy
* Histologically confirmed CD30+ disease by central laboratory assessment and pathology review
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
* Male participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
* Clinical laboratory values as specified in protocol
* A 3-week washout period is required from previous treatments (with the exception of a 12-week washout for antibody-directed or immunoglobulin-based immune therapy, or other monoclonal antibody therapies), unless it is not in the best interest of the patient in the opinion of the investigator. Individual cases should be discussed with the project clinician before enrollment.

Exclusion Criteria:

* A concurrent diagnosis of systemic ALCL, or other non Hodgkin lymphoma (excluding LyP) or Sezary syndrome or B2 disease
* Participants with cardiovascular conditions specified in protocols
* Participants with history of another primary malignancy not in remission for at least 3 years
* Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML);
* Known human immunodeficiency virus (HIV) infection, hepatitis B or Hepatitis C infection
* Oral retinoid therapy for any indication within 3 weeks of study entry
* Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
* Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
* Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Answer: A