| Eligibility |
Inclusion Criteria:
1. Patients must have a biopsy confirmed diagnosis based on a combination of histological
and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous
anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase
II trial. There is no specific limit or validated amount other than positive cells on
1HC cells in tumor cells.
2. Patients with pc-ALCL that has spread systemically (e.g. to lymph nodes, bone marrow
or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for
at least 6 months before systemic involvement was confirmed. MF patients must be stage
IB or greater.
3. Systemic involvement (i.e., nodal, bone marrow or visceral organ involvement) will be
evaluated by CT and/or PET and bone marrow biopsy(if indicated on patients with blood
involvement) in patients with pc-ALCL or MF at baseline.
4. Patients' biopsies must be histologically confirmed CD30 positive within 36 months of
enrollment.
5. pc-ALCL and MF patients must have progressed or relapsed after treatment with local
radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy
of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30
antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin,
vincristine, and prednisone). pc-ALCL classified patients are required to have one or
more cutaneous tumors that by history have been present for at least 3 months.
6. All patients must be considered an eligible candidate for systemic therapy as
determined by the investigator. To be eligible, LYP patients must be in need of
systemic therapy ie have scarring or active lesions (>/=10 per month), or any number
of active lesions on face, hands or feet.
7. Patients must have the following minimum wash-out from previous treatments: a. >/= 4
weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment
with other anticancer investigational agents. b. > 2 weeks for oral methotrexate,
retinoids or biological response modifiers therapy for any indication, or topical
prescription or topical therapy. c. >/= 12 weeks for any immunotherapy (e.g.,
monoclonal antibody). Patients with rapidly progressive disease may be treated earlier
than the required washout period; patients should have recovered from prior
treatment-related toxicities
8. Patients must have an ECOG performance status of </= 2.
9. Patients must be at least 18 years of age.
10. Patients must be available for periodic blood sampling, study-related assessments, and
management of toxicity at the treating institution.
11. Females of childbearing potential [a female not post menopausal for at least 12 months
or not surgically sterilized] must have a negative beta-HCG pregnancy </=7 days prior
to Day 1 of Cycle 1. If the pregnancy test is outside institutional normal range at
pretreatment, the subject must have a second pregnancy test. If the second pregnancy
test is outside institutional normal range then a gynecology consult is needed to
confirm the subject is not pregnant. All patients must agree to use an effective
contraceptive method during the course of the study.
12. Patients must give written informed consent. A copy of the signed informed consent
form will be retained in the patient's chart.
13. The following required baseline laboratory data: absolute neutrophil count (ANC) >/=
1000/microliter, platelets >/= 50,000/µL (unless documented bone marrow involvement
with lymphoma), bilirubin </= 1.5X upper limit of normal (ULN) or </= 3X ULN for
patients with Gilbert's disease, serum creatinine </= 1.5X ULN, alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.5X ULN.
Exclusion Criteria:
1. Concomitant corticosteroid use for systemic or topical treatment of skin disease is
not allowed except a dose of steroid of no more than 20 mg of prednisone or its
equivalence is allowed of asthma, COPD or IBD .Stable use of topical corticosteroids
of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4) and
tumor stage (T3) with intense pruritus.
2. Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or
cutaneous viral, bacterial or fungal infection.
3. Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
4. Patients with known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation that includes trehalose, sodium citrate, and
polysorbate 80.
5. Patient with a history of other malignancies during the past three years. (The
following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in
situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on
biopsy or a squamous intraepithelial lesion on PAP smear.)
6. Patients with congestive heart failure, Class III or IV, by the NYHA criteria.
7. Patients who are pregnant or breastfeeding.
8. Patients with any serious underlying medical condition that would impair their ability
to receive or tolerate the planned treatment.
9. Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent.
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