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A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis


Phase 2
18 Years
N/A
Not Enrolling
Both
Large Cell Lymphoma

Thank you

Trial Information

A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis

Inclusion Criteria


Inclusion Criteria

- Patients must have a definite diagnosis.

- Patients must be histologically confirmed CD30 positive within 3 months of enrollment

- Patients with pcALCL must have target lesions present for at least 1 month without
spontaneous regression

- pcALCL patients must have failed treatment with local radiation therapy, or failed
systemic therapy of a single agent

- Patients must be considered an eligible candidate for systemic therapy as determined
by the investigator

- All patients must have a three week wash-out from previous treatments, unless in the
opinion of the investigator it is not in the best interest of the patient, at which
point the individual case must be discussed with the medical monitor prior to
enrollment.

- Patients must have an ECOG performance status of < 2 (Appendix B) and a life
expectancy > six months.

- Patients must be at least 18 years of age.

- Patients must be available for periodic blood sampling, study-related assessments,
and management of toxicity at the treating institution.

- Females of childbearing potential must have a negative HCG pregnancy test result
within three days of enrollment. All patients must agree to use an effective
contraceptive method during the course of the study.

- Patients must give written informed consent.

- Required baseline laboratory data: Absolute neutrophil count greater than or equal to
to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin
less than or equal to 1.5 times ULN, Serum creatinine less than or equal to 1.5 times
ULN, BUN less than or equal to 1.5 times ULN, SGOT less than or equal to 2.5 ULN,
SGPT less than or equal to 2.5 ULN

Criteria for Exclusion

- Patients with Sezary syndrome, or any type of lymphoproliferative disease other than
pcALCL, T-MF or LyP

- Patients with systemic ALCL or extracutaneous involvement of cutaneous ALCL

- Patients with known active systemic viral, bacterial, or fungal infection

- Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive

- Patients who have been treated previously with any anti-CD30 antibody

- Patients with a known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation

- Patients with a history of other malignancies during the past five years with the
exception of adequately treated basal or squamous cell skin cancer or cervical
carcinoma in situ

- Patients with symptomatic cardiac disease including ventricular dysfunction, coronary
artery disease, or arrhythmias

- Patients who are pregnant or breastfeeding

- Patients with any serious underlying medical condition that would impair their
ability to receive or tolerate the planned treatment

- Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate in patients with pcALCL, T-MF, and LyP

Authority:

United States: Food and Drug Administration

Study ID:

SG030-0004

NCT ID:

NCT00099255

Start Date:

September 2004

Completion Date:

February 2007

Related Keywords:

  • Large Cell Lymphoma
  • Keyword?
  • Primary Cutaneous Anaplastic Large Cell Lymphoma
  • Large Cell Transformation of Mycosis Fungoides
  • Lymphomatoid Papulosis
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Mycosis Fungoides
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphomatoid Papulosis
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford UniversityStanford, California  94305
University of Illinois at ChicagoChicago, Illinois  60612
University of MinnesotaMinneapolis, Minnesota  55455
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Vanderbilt UniversityNashville, Tennessee  37232-6305
Memorial Sloan-KetteringNew York, New York  
Johns HopkinsBaltimore, Maryland  21231
University of California at Los AngelesLos Angeles, California  90095
YaleNew Haven, Connecticut  06520
Northwestern UniverstiyChicago, Illinois  60611
Cleveland UniversityCleveland, Ohio  44106
Kaiser Permanente - Oncology ResearchPortland, Oregon  97227