Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients with Metastatic Malignant Melanoma
- Conditions
- Metastatic Malignant MelanomaMedDRA version: 9.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanoma
- Registration Number
- EUCTR2007-006713-16-GB
- Lead Sponsor
- ImClone Systems Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 104
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 6 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/µL, hemoglobin = 9 g/dL and platelets = 100,000 cells/µL).
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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, 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method