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Safety Study of IMC-1121B With or Without Dacarbazine to Treat Metastatic Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: September 17, 2007   Last Updated: August 20, 2009   History of Changes
Sponsored by: ImClone LLC
Information provided by: ImClone LLC
ClinicalTrials.gov Identifier: NCT00533702
  Purpose

The primary objective of this study is to determine the progression-free survival (PFS) of patients with previously untreated metastatic malignant melanoma when treated with IMC 1121B alone or in combination with dacarbazine.


Condition Intervention Phase
Metastatic Malignant Melanoma
Biological: IMC-1121
Drug: Dacarbazine
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • The primary efficacy endpoint for this study is PFS. PFS is defined as the time from randomization to the first evidence of progression as defined by RECIST or death from any cause. [ Time Frame: Patients will be evaluated for response after every 2 cycles of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 at 6 weeks and 12 weeks 5)Determine 12-week response rate [ Time Frame: Measure stable disease rate at 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 104
Study Start Date: August 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IMC-1121B: Experimental
IMC-1121B
Biological: IMC-1121
IMC-1121B injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL) of product, administered as an i.v. infusion at 10 mg/kg every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
IMC-1121 + dacarbazine: Active Comparator
IMC-1121 + dacarbazine
Biological: IMC-1121
IMC-1121B injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL) of product, administered as an i.v. infusion at 10 mg/kg every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Drug: Dacarbazine
Dacarbazine 1000 mg/m2 administered as an i.v. infusion once every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

Detailed Description:

The purpose of this study is to determine the antitumor activity, safety profile,pharmacodynamic activity, and pharmacokinetics of IMC-1121B when used as monotherapy or in combination with dacarbazine in patients with metastatic malignant melanoma who have not received prior systemic therapy for this disease.

  Eligibility

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

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.16
  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] ≤ 2.5 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.

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 (including therapy for adjuvant or advanced disease).
  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 breastfeeding.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533702

Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
Scottsdale Medical Specialists
Scottsdale, Arizona, United States, 85258
United States, California
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, United States, 93720
St Mary's Medical Center
San Francisco, California, United States, 94117
United States, Colorado
Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80045
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Mississippi
The Jones Clinic, PC
Oxford, Mississippi, United States, 38655
United States, Montana
Montana Cancer Specialists
Missoula, Montana, United States, 59806
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
NYU Clinical Cancer Center
New York City, New York, United States, 10016
United States, Pennsylvania
Abington Hematology Oncology Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Center for Oncology Research and Treatment
Dallas, Texas, United States, 75230
Agop Bedikian, MD
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: Jonathan Schwartz, MD ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers: CP12-0604
Study First Received: September 17, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00533702     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Phase II
Melanoma
IMC-1121B
ImClone

Study placed in the following topic categories:
Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Neuroendocrine Tumors
Melanoma

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

ClinicalTrials.gov processed this record on September 10, 2009