Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB
Brief Summary: The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis fungoides) patients.


Options:
A: Inclusion Criteria:

* Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy
* A Karnofsky performance score \> 60
* No previous PUVA treatment
* Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative
* Acceptable organ function defined as follows:

SGOT (AST) and SGPT (ALT) \< 2.5 times the upper limit of normal for the institution

* Creatinine \< 2 times the upper limit of normal for the institution
* No evidence of severe cardiac insufficiency (NYHA grade III-IV)
* Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within seven (7) days prior to randomization
* Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
* Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment
* Written informed consent

Exclusion Criteria:

* Pregnancy and Lactation
* Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome
* Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome
B: DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides

  * Stage IIB, IVA, or IVB
* Refractory or recurrent disease after at least 2 of the following prior therapies:

  * Local and/or systemic steroids
  * Retinoids
  * Interferon alfa
  * Local carmustine
  * Systemic chemotherapy
  * Psoralen and ultraviolet A (PUVA) light therapy
* No CNS involvement
* No erythroderma (T4)

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count at least 1,500/mm\^3
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

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

Renal

* Creatinine no greater than 1.5 times ULN

Cardiovascular

* LVEF normal by echocardiography or radionuclide angiocardiography

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 years after study participation
* No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up
* No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy)
* No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* More than 2 weeks since prior immunotherapy

Chemotherapy

* See Disease Characteristics
* Prior systemic chemotherapy allowed provided all of the following conditions are met:

  * Cumulative anthracycline dose is less than 200 mg/m\^2
  * No allergy to anthracyclines
  * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg)
* More than 2 weeks since prior chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent systemic steroids

Radiotherapy

* More than 2 weeks since prior radiotherapy

Surgery

* Not specified

Other

* Recovered from toxic effects of prior therapy, excluding alopecia
* No other concurrent anticancer therapy
C: Inclusion Criteria:

* Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication
* At least the following wash-out from prior treatments:

  * ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody)
  * \> 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy
  * \> 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
* At least 18 years of age
* ECOG performance status of ≤ 2
* Must be able to commit to study schedule
* Absolute neutrophil count (ANC) ≥ 1000/uL
* Platelets ≥ 50,000/uL
* Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN)
* Serum creatinine ≤ 2X ULN
* Alanine aminotransferase (ALT) ≤ 3X ULN
* Aspartate aminotransferase (AST) ≤ 3X ULN
* Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease
* Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day)
* Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
* Known to be Hepatitis B or Hepatitis C antibody positive
* HIV-positive with have a measurable viral load while on antiretroviral medication
* Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
* History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy).
* Pregnant
* Breastfeeding
* Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
* Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment.
* Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
D: 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

Answer: A