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Study Summary
No. 2007-0019:.......Melanoma......Agop Y. Bedikian......Melanoma Medical Oncology
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Study Summary Title
Study Summary
Number:		2007-0019
Study Title:Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients with Metastatic Malignant Melanoma
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Physician New Patient Referral
Name:Agop Y. BedikianPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Melanoma Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2921
Contact us about clinical trials
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General Information
Disease Group:MelanomaSupported By:Imclone Systems Inc.
ImClone Systems Incorporated
Phase of Study:Phase IIReturn
Visit:		every 3 weeks
Treatment
Agents:		Dacarbazine
IMC-1121B		Home Care:None needed
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		The goal of this clinical research study is to see if giving IMC -1121B alone
or in combination with DTIC (dacarbazine), to patients with melanoma, can help
to keep the disease from getting worse. The safety of these treatments will
also be studied.
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Study Objectives / Outcomes
Primary Objectives
-The primary objective is to determine the progression-free survival (PFS) of patients with metastatic malignant melanoma who have not received prior chemotherapy for metastatic disease when treated with IMC-1121B alone or in combination with dacarbazine.

  • Secondary Objectives
    The secondary objectives of this study are to:
    - Assess the safety and tolerability of IMC-1121B alone and in combination with dacarbazine
    - Measure overall response rate (ORR)
    - Determine median duration of response
  • - Measure stable disease rate
  • - Determine 12-week response rate

    Exploratory Analysis
  • - Assess potential surrogates of IMC-1121B pharmacodynamic activity obtained from serum samples
  • - Assess potential biomarkers (including VEGF) in tumor tissue and their potential association with clinical endpoints
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    Study Status Information
    Study Activation / Registration Date:04/10/2008
    IRB Review and Approval Date:09/12/2007
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Closed
    Projected Accrual:104
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) The patient has histologically or cytologically confirmed cutaneous malignant melanoma that is American Joint Committee on Cancer (AJCC) stage IV (metastatic).

    2) The patient is >/= 18 years of age.

    3) The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.

    4) The patient has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy.

    5) The patient has a life expectancy > 3 months.

    6) The patient has evidence of measurable disease as defined by RECIST.

    7) The patient has resolution of all clinically significant toxic effects of prior cancer therapy to grade </= 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE).

    8) The patient has adequate hematological functions (absolute neutrophil count [ANC] >/= 1500 cells/microliter, hemoglobin >/= 9 g/dL and platelets >/= 100,000 cells/microliter).

    9) The patient has adequate hepatic function (bilirubin within normal limits [WNL], aspartate transaminase [AST] and/or alanine transaminase [ALT] </=3.0 times the upper limit of normal [ULN], or </= 5.0 times the ULN if the transaminase elevation is due to liver metastases).

    10) The patient has serum creatinine </= 1.5 x ULN (or a calculated creatinine clearance > 60 mL/min).

    11) The patient's urinary protein </= 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is >/= 2+, a 24-hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).

    12) The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) </= 1.5 and a partial thromboplastin time (PTT) </= 1.5 X ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).

    13) The patient is able to provide informed written consent.

    14) The patient, if sexually active, must be post-menopausal (last menstrual period > 2 years prior to study), surgically sterile, or is using an effective method of contraception in the opinion of the investigator.

    15) The patient, if female, must have a negative serum pregnancy test upon entry into this study.
    Exclusion Criteria:1) The patient has mucosal or intra-ocular melanoma.

    2) The patient has known or suspected brain or leptomeningeal metastases.

    3) The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma.

    4) The patient has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (not including adjuvant therapy).

    5) The patient has a concurrent active malignancy other than adequately treated non melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years.

    6) The patient has a nonhealing wound or ulcer.

    7) The patient has a known alcohol or drug dependency.

    8) The patient is pregnant or lactating.

    9) The patient has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results.

    10) The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, uncontrolled hypertension (defined as resting blood pressure over 140/90mmHg) or any other serious uncontrolled medical disorders in the opinion of the investigator.

    11) The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.

    12) The patient has uncontrolled or poorly controlled hypertension despite standard medical management (>140 mmHg systolic or > 90 mmHg diastolic).
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    Links
    Registration Number: NCT00533702
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

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