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An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Stage IV Melanoma

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Trial Information

An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma

This open label study consists of two parts. Part I, the Phase I component of the study,
will be conducted at a single center, and will enroll up to 18 patients with histologically
documented Stage IV melanoma (per the American Joint Committee on Cancer [AJCC] criteria)
that is not currently amenable to surgical resection or other therapies.

A specified premedication regimen consisting of ranitidine, diphenhydramine, and
dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose
of KW-2871.

Planned doses of KW-2871 are 60 mg/m2, 80 mg/m2, 100 mg/m2

After identification of the MTD, 30 patients will be enrolled at that dose level in Part II
of the study. If no MTD is identified after treatment with the 100 mg/m2 dose level, the
dose administered in Part II of the study will be 100 mg/m2. If the MTD is determined as 60
mg/m2, this study will be closed to further patient accrual and will not proceed to Part II.

Inclusion Criteria:

1. Male or female patients > 18 years of age

2. Patients with documented Stage IV melanoma (histologically- or cytologically-proven,
as per AJCC criteria) that is not currently amenable to surgical resection (due to
either medical contraindication or non-resectability of tumor)

3. Patients may have measurable or non-measurable disease, in accordance with the RECIST

4. Failure of at least one, but no more than 3, standard treatment regimen(s) for
metastatic disease

5. Patients must have adequate end-organ function including:

1. Hemoglobin > 9.0 g/dL

2. ANC > 1500/mm3

3. Platelet count > 100,000/ mm3

4. Serum creatinine < 1.5x the upper limit of normal

5. Total bilirubin < 1.5 mg/dL

6. AST or ALT < 3 X the upper limit of normal

7. Serum albumin > 2.5 g/dL

6. Patients with an ECOG performance status of 0, 1, or 2, and an expected survival of >
12 weeks

7. Patients must be able to provide written informed consent (must be obtained at time
of patient screening)

8. Female patients of childbearing potential must not be pregnant or breast-feeding and
must have a negative serum pregnancy test within 72 hours prior to administration of
the first dose of KW-287. Women are NOT considered of child-bearing potential after
surgical sterilization with physician-documented hysterectomy or tubal ligation, or
if post-menopausal; post-menopausal status is defined as absence of menses for at
least two consecutive years and a serum FSH > 30 IU/L in the absence of hormone
replacement therapy

9. At least four weeks from last dose of systemic chemotherapy (6 weeks if mitomycin C
or a nitrosourea) and recovery from any acute toxicity

10. At least four weeks from last radiotherapy treatment, with recovery from any acute

Exclusion Criteria:

1. Women who are pregnant or lactating and women of childbearing potential and fertile
men not agreeing to a medically effective method of contraception. Women of
childbearing potential will be informed as to the potential risk of procreation while
participating in this study and will be advised that they must use effective
contraception (e.g. oral contraceptive or long-term injectable or implantable
hormonal contraceptive, double-barrier methods such as condom and diaphragm, condom
and foam, condom and sponge or intra-uterine devices) during the treatment period and
for a period of 3 months following the completion of dosing.

2. Patients with significant cardiovascular disease as defined by The New York Heart
Association Classification (Class III or higher)

3. Patients with symptomatic or known brain metastases unless patient has undergone
radiotherapy (or treatment with gamma knife) or resection of an isolated lesion and
maintenance steroids are not required

4. Patients with a history of another malignancy within the last 2 years with the
exception of:

- Treated, non-melanoma skin cancers

- Carcinoma in situ of the breast or cervix

- History of T1a or b carcinoma of the prostate detected incidentally and
comprising <5% of resected tissue, with PSA within normal limits since resection

5. Patients with any uncontrolled infection or other intercurrent illness

6. Patients with any history of other disease, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of an
underlying disease or condition that contraindicates the use of an investigational
drug or that might affect interpretation of the results of the study or render the
subject at high risk from treatment complications

7. Patients with known HIV infection

8. Patients with inadequate recovery from any prior surgical procedure

9. Patients with psychiatric disorders or altered mental status that would preclude
understanding of the informed consent process and/or completion of the necessary

10. Patients with any prior monoclonal antibody therapy for melanoma

11. Patients previously treated with any other immunotherapy, vaccine, or biological
response modifier therapy for melanoma, either during or within four weeks prior to
study entry

12. Patients with systemic hormonal therapy, either during or within four weeks prior to
first dose of KW-2871, unless for appetite stimulation

13. Patients requiring maintenance systemic steroid therapy for any condition


Type of Study:


Study Design:

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

Outcome Measure:

To determine the MTD and a recommended Phase II dose of KW-2871 administered with a specified premedication regimen (rantidine, diphenhydramine, and dexamethasone) in patients with Stage IV melanoma.

Outcome Description:

Until determination of MTD or recommended dose for evaluation

Outcome Time Frame:

up to 1 year

Safety Issue:


Principal Investigator

Andres Forero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center University of Alabama


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

Related Keywords:

  • Stage IV Melanoma
  • Melanoma
  • Monoclonal Antibody
  • Anti-GD-3
  • Melanoma



H. Lee Moffitt Cancer CenterTampa, Florida  33612
Comprehensive Cancer Center- University of Alabama at BirminghamBirmingham, Alabama  35294