- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00024011
PS-341 in Treating Patients With Metastatic Malignant Melanoma
A Phase II Study of PS-341 in the Treatment of Metastatic Malignant Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who are progression-free
Time Frame: 18 weeks
|
Confidence intervals for the true success proportion will be calculated.
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18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to 2 years
|
|
Overall survival
Time Frame: Time from registration to death due to any cause, assessed up to 2 years
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The distribution of survival time will be estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Svetomir Markovic, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02409
- N01CM17104 (U.S. NIH Grant/Contract)
- MC007A
- CDR0000068883 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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