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Phase II Study of the Anti-Ganglioside GD3 Mouse/Human Chimeric Antibody KW2871 Combined With High Dose Interferon-alpha2b in Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma, Cutaneous Melanoma

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Trial Information

Phase II Study of the Anti-Ganglioside GD3 Mouse/Human Chimeric Antibody KW2871 Combined With High Dose Interferon-alpha2b in Patients With Metastatic Melanoma


This is an open label study of KW2871 plus high dose IFN-α2b (HDI) in patients with
measurable metastatic melanoma. All eligible patients will receive KW2871 IV every two weeks
(Wednesday) starting on week 1. HDI will also be given at a dose of 20 MU/m2 IV for five
consecutive days (Monday thru Friday) per week for four weeks, and then 10 MU/m2 sc three
times a week (Monday, Wednesday, Friday). Patients will be treated with KW2871-HDI
combination therapy until disease progression requiring treatment intervention that would
interfere with the interpretation of the study results.


Inclusion Criteria:



1. >18 years of age

2. Histologically proven metastatic cutaneous, mucosal, or unknown primary melanoma

3. Measurable disease using response evaluation criteria in solid tumors RECIST criteria

4. Are ambulatory (ECOG performance status 0 or 1) or expected survival >/= 4 months

5. Within the last two weeks prior to study day 1, the following laboratory parameters
should be within the ranges specified (Table 4):

Table 4: Baseline peripheral laboratory values acceptable for enrollment

- Hemoglobin >/= 9 g/dL

- Platelets >/= 100 x 109/L

- Neutrophil count >/= 1.5 x 109/L

- INR
- Serum creatinine
- Serum total bilirubin
- AST(SGOT)/ALT(SGPT)
6. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Other malignancy within three years prior to study entry for which they received
active treatment, except for treated melanoma or non-melanoma skin cancer and
cervical and breast carcinoma in situ

2. Mental impairment that may compromise the ability to give informed consent and comply
with the study requirements

3. Participation in any other clinical trial involving chemotherapy, radiotherapy or
other immunotherapy within four weeks prior to study enrollment

4. Prior exposure to anti-GD3 antibodies

5. Pregnancy or breastfeeding

6. Women of childbearing potential who refuse or are unable to use effective means of
contraception

7. Active autoimmune or other disorders that require systemic treatment with
immunomodulatory or immunosuppressant medications (i.e. corticosteroids,
cyclophosphamide, methotrexate, other biologics). Corticosteroids at substitution
doses are allowed

8. Metastatic brain disease is allowed provided that appropriate treatment has been
administered (surgery or irradiation) and two month follow-up by brain MRI shows
disease control (stability or regression)

9. Autoimmune-related hypothyroidism and vitiligo-like depigmentation are allowed
provided the patient is medically stable with treatment (thyroid-hormone replacement
or observation)

10. Serious medical illness, such as cardiovascular disease [uncontrolled congestive
heart failure or hypertension, active ischemic disease of the heart (angina), recent
(<3 months) myocardial infarction, severe cardiac arrhythmia], bleeding disorders,
obstructive or restrictive pulmonary diseases, active systemic infections requiring
antibiotics, serious intercurrent illness requiring hospitalization, inflammatory
bowel disorders, or significant psychiatric disease, which in the opinion of the
principal investigator would prevent adequate informed consent or render study
treatment unsafe or contraindicated.

11. Subjects with clinical suspicion of HIV or hepatitis will undergo the following viral
tests:

- HIV (human immunodeficiency virus): subjects must have negative antibodies

- HBV (hepatitis B virus): subjects must have negative antigens

- HCV (hepatitis C virus): subjects must have a negative test for serum antibodies

- If any of the tests are positive patients will be excluded from the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

ongoing

Safety Issue:

No

Principal Investigator

John Kirkwood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

LUD2007-001

NCT ID:

NCT00679289

Start Date:

March 2008

Completion Date:

December 2012

Related Keywords:

  • Metastatic Melanoma
  • Cutaneous Melanoma
  • KW2871
  • ecromeximab
  • anti-ganglioside
  • antibody
  • interferon alpha
  • Metastatic melanoma
  • Melanoma
  • Skin Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
University of Chicago HospitalChicago, Illinois  60637-1470