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MelanomaPhase 2NCT00027586

Imatinib Mesylate in Treating Patients With Metastatic Melanoma

A Phase 2 study testing Imatinib mesylate (STI571) in people with Melanoma and Skin Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for metastatic melanoma. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic melanoma. Read more about this study

Who is it for?
Any age
Conditions the study is for
Melanoma, Skin Neoplasms
What is being tested?
Imatinib mesylate (STI571)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Sep 2001to Jan 2005
Phase
Phase 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient must have a biopsy proven diagnosis of metastatic melanoma. Patients will be enrolled if at least 20% of the tumor cells stain by immunohistochemistry (see Appendix E for methodology) for:
  • PDGF receptor alpha or beta, or
  • KIT (CD 117) expression by tumor documented by DAKO antibody staining, or
  • c-abl, ARG.
  • Patients must have measurable indicator metastasis, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan or in case of obviously visible cutaneous tumors. Besides the indicator lesion(s), the patient must have at least one other biopsiable metastasis in a subcutaneous site or lymph node.
  • Radiographic studies used to assess disease must have been performed within 28 days prior to registration. If a target lesion has been previously embolized, perfused or irradiated, there must be objective evidence of progression before start of therapy to be considered for response assessment.
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  • Patient will not have symptomatic central nervous metastases. However, patients with small asymptomatic metastases will not be excluded provided they are not on steroids and the lesions are not associated with significant edema. Patients with brain metastases as the only site of disease are not eligible.
  • Patient may have received prior interferon and/or one other systemic treatment regimen (chemotherapy, biotherapy, or biochemotherapy). Active immunotherapy (cancer vaccines) will not be included in the tally of prior treatments.
  • Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration, and this extends to 42 days if the patient received a nitrosourea. Patients must not have had a major surgery within 14 days prior to registration.
  • Patient must have a ECOG performance status < 2 or Karnofsky performance status > 60% (see Appendix C).
  • Patient must have resolution of transient toxicities from any prior therapy to Grade 1 (NCI-CTC version 2.0, see Appendix B).
  • Patients must have normal organ and marrow function as assessed within 14 days prior to registration and as defined below:
  • leukocytes > 3,000/mL absolute neutrophil count > 1,500/mL platelets > 100,000/mL total bilirubin < 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal creatinine < 1.5 X institutional upper limit of normal
  • Patient must have a hemoglobin > 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to registration.

Who cannot join

  • Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, myocardial infarction within 2 months of study, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not have a severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection).
  • Patient must not be pregnant or nursing because Gleevec may be harmful to the developing fetus and newborn (see Section 3.0 for more detail). Women/men of reproductive potential must agree to use an effective contraceptive method. Because of the potential interaction with oral contraceptives both male and female patients of reproductive potential must agree to employ a barrier method of contraception (condom, diaphragm) throughout the study and for up to 3 months following discontinuation of Gleevec.Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to registration. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Patient with medical or psychological conditions that, in the opinion of the investigator, make the patient unable to tolerate or complete the treatment, or to grant reliable informed consent are not eligible for this study.
  • Patient must not be taking therapeutic doses of coumadin (warfarin) as anticoagulation at the time of registration. Patients requiring therapeutic anticoagulation may use low-molecular weight heparin (e.g., Lovenox) or other agents, and mini-dose coumadin (1 mg po QD) as prophylaxis is allowed.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: Phase II Trial of Gleevec (Imatinib Mesylate, STI-571) in Metastatic Melanoma

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic melanoma.

Read the detailed description

OBJECTIVES:

  • Determine the clinical activity of imatinib mesylate (STI571) in patients with metastatic melanoma.
  • Determine the side effects of this drug in these patients.
  • Correlate molecular studies with responsiveness to this drug in these patients.

OUTLINE: Patients receive oral imatinib mesylate (STI571) twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-78 patients will be accrued for this study within 6-15 months.

Being tested
Imatinib mesylate (STI571)
Keywords
stage IV melanoma, recurrent melanoma, Imatinib Mesylate, Gleevec, protein tyrosine kinases, PTK, Gleevec targets, metastatic melanoma
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

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

  • Imatinib mesylate (STI571)Drug

    Also called Gleevec, Imatinib, NSC-716051

    400 mg twice a day orally

Study groups in NCT00027586
Study groupRoleWhat they receive
Imatinib MesylateExperimental400 mg twice a day orally
Receives: Drug: Imatinib mesylate (STI571)

What is being measured

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

  1. Response rate

    Measured: 6 week intervals

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionJan 2005
  4. Study completionJan 2005

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027586
Sponsor's protocol ID
ID01-284
Other IDs
P30CA016672, MDA-ID-01284, NCI-5345, CDR0000069045
Status last verified
Oct 2018
First submitted
7 Dec 2001
Last updated
31 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Kim KB, Eton O, Davis DW, Frazier ML, McConkey DJ, Diwan AH, Papadopoulos NE, Bedikian AY, Camacho LH, Ross MI, Cormier JN, Gershenwald JE, Lee JE, Mansfield PF, Billings LA, Ng CS, Charnsangavej C, Bar-Eli M, Johnson MM, Murgo AJ, Prieto VG. Phase II trial of imatinib mesylate in patients with metastatic melanoma. Br J Cancer. 2008 Sep 2;99(5):734-40. doi: 10.1038/sj.bjc.6604482. Epub 2008 Aug 19.

    PubMed 18728664

  • Wyman K, Atkins MB, Prieto V, Eton O, McDermott DF, Hubbard F, Byrnes C, Sanders K, Sosman JA. Multicenter Phase II trial of high-dose imatinib mesylate in metastatic melanoma: significant toxicity with no clinical efficacy. Cancer. 2006 May 1;106(9):2005-11. doi: 10.1002/cncr.21834.

    PubMed 16565971

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib mesylate (STI571) in people with Melanoma and Skin Neoplasms, run by M.D. Anderson Cancer Center at 1 site 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 14 inclusion and 6 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: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate (time frame: 6 week intervals). 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 NCT00027586, which also lists 2 linked publications.

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 31 Oct 2018.

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