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Stage IV MelanomaPhase 1/2NCT00199342

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

A Phase 1/2 study testing KW-2871 in people with Stage IV Melanoma, run by Kyowa Kirin, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Melanoma
What is being tested?
KW-2871
How many people
5 participants
Where
2 sitesUnited States
Study dates
Nov 2004to Oct 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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
  • At least four weeks from last dose of systemic chemotherapy (6 weeks if mitomycin C or a nitrosourea) and recovery from any acute toxicity
  • At least four weeks from last radiotherapy treatment, with recovery from any acute toxicity

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Patients requiring maintenance systemic steroid therapy for any condition
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Comprehensive Cancer Center- University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 22612

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
KW-2871
Keywords
Melanoma, Monoclonal Antibody, Anti-GD-3
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KW-2871Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 1 year

Secondary outcomes (3)

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

    Measured: up to 1 year

  2. 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.

    Measured: up to 1 year

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

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionOct 2005

Why it stopped: Occurrence of 2 dose-limiting toxicities at the initial dose level (60 mg/m2) in Part I.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00199342
Sponsor's protocol ID
2871-US-002
Status last verified
May 2024
First submitted
12 Sep 2005
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KW-2871 in people with Stage IV Melanoma, run by Kyowa Kirin, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Occurrence of 2 dose-limiting toxicities at the initial dose level (60 mg/m2) in Part I.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00199342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

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