A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

NCT00199342 | Terminated Phase 1

• 1 other identifier: 2871-US-002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.

Conditions

Stage IV Melanoma

Keywords

Melanoma; Monoclonal Antibody; Anti-GD-3

Outcome Measures

Primary Outcomes (1)

• 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.

  Until determination of MTD or recommended dose for evaluation

  up to 1 year

Secondary Outcomes (3)

• To characterize the safety and tolerability profile of KW-2871 when administered with a specified premedication regimen.

  up to 1 year

• To obtain a preliminary assessment of antineoplastic activity of KW-2871, as measured by the number of objective antitumor responses, duration of response, time to progression (TTP) and survival in this patient population.

  up to 1 year

• To characterize the pharmacokinetic profile of indicated dose levels of KW-2871 when administered with this specified premedication regimen.

  up to 1 year

Interventions

KW-2871 DRUG

potentially therapeutic monoclonal antibody for the treatment of advanced stage four melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \> 18 years of age
• 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)
• Patients may have measurable or non-measurable disease, in accordance with the RECIST criteria.
• Failure of at least one, but no more than 3, standard treatment regimen(s) for metastatic disease
• Patients must have adequate end-organ function including:
• Hemoglobin \> 9.0 g/dL
• ANC \> 1500/mm3
• Platelet count \> 100,000/ mm3
• Serum creatinine \< 1.5x the upper limit of normal
• Total bilirubin \< 1.5 mg/dL
• AST or ALT \< 3 X the upper limit of normal
• Serum albumin \> 2.5 g/dL
• Patients with an ECOG performance status of 0, 1, or 2, and an expected survival of \> 12 weeks
• Patients must be able to provide written informed consent (must be obtained at time of patient screening)
• 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

You may not qualify if:

• 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.
• Patients with significant cardiovascular disease as defined by The New York Heart Association Classification (Class III or higher)
• 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
• 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
• Patients with any uncontrolled infection or other intercurrent illness
• 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
• Patients with known HIV infection
• Patients with inadequate recovery from any prior surgical procedure
• Patients with psychiatric disorders or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
• Patients with any prior monoclonal antibody therapy for melanoma
• 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
• Patients with systemic hormonal therapy, either during or within four weeks prior to first dose of KW-2871, unless for appetite stimulation

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (2)

Comprehensive Cancer Center- University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 22612, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

ecromeximab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andres Forero, MD

  Comprehensive Cancer Center University of Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2004
• Primary Completion: October 1, 2005
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (2)