PS-341 in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024011
First received: September 13, 2001
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die


Condition Intervention Phase
Recurrent Melanoma
Stage IV Melanoma
Drug: bortezomib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of PS-341 in the Treatment of Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients who are progression-free [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Confidence intervals for the true success proportion will be calculated.


Secondary Outcome Measures:
  • Objective response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) in terms of tumor/lesion size and change [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    The distribution of survival time will be estimated using the method of Kaplan-Meier.


Enrollment: 50
Study Start Date: July 2001
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bortezomib)
Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341.

II. Determine the objective response rate of patients treated with this drug. III. Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3-6 months for up to 2 years after registration.

PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study within 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic malignant melanoma
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm
  • Absolute neutrophil count (ANC) >= 1500/uL
  • PLT >= 100,000/uL
  • Total bilirubin =< 2.5 x institutional upper normal limit (UNL)
  • AST =< 2.5 x UNL
  • Creatinine =< 1.5 x UNL or calculated creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x UNL using the Cockcroft-Gault formula
  • Life expectancy of >= 3 months
  • ECOG performance status 0 or 1
  • Capable of understanding the investigational nature, potential risks and benefits of the study and willing to sign the written informed consent document

Exclusion Criteria:

  • Any of the following:

    • Any prior chemotherapy
    • Immunotherapy =< 4 weeks prior to study entry
    • Biologic therapy =< 4 weeks prior to study entry
    • Radiation therapy =< 4 weeks prior to study entry
    • Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
    • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
  • Known brain metastases requiring active treatment; NOTE: these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS-341
  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris, cardiac arrhythmia
    • Psychiatric illness that would limit compliance with study requirements
  • HIV-positive patients receiving combination anti-retroviral therapy; NOTE: patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with PS-341; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, subcutaneous implants, intrauterine device [IUD], abstinence, etc.)
    • NOTE: this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
  • Only non-measurable disease, including lesions not clearly measurable in one dimension, small lesions (longest diameter < 20 mm), and truly non-measurable lesions, which include the following as per RECIST criteria:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024011

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Svetomir Markovic Mayo Clinic
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024011     History of Changes
Other Study ID Numbers: NCI-2012-02409, MC007A, N01CM17104, CDR0000068883
Study First Received: September 13, 2001
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014