Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00066196
First received: August 5, 2003
Last updated: January 14, 2008
Last verified: January 2008
  Purpose

The primary objectives of this study are:

  • To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.
  • To determine the safety of MEDI-522 ± DTIC in this patient population.

Condition Intervention Phase
Melanoma
Malignant Metastatic Melanoma
Biological: MEDI--522
Biological: Integrin + Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Explore antitumor activity of MEDI-522 in patients with metastatic melanoma. [ Time Frame: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the safety of MEDI-522 and/or DTIC in this patient population. [ Time Frame: Every week until disease progression, and 30 days after disease progression. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: August 2003
Study Completion Date: June 2007
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
Integrin + Dacarbazine
Biological: Integrin + Dacarbazine
supplied in other formulations
Active Comparator: 1
MEDI-522
Biological: MEDI--522
IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.

Detailed Description:

This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).

  Eligibility

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

Inclusion

Patients must meet all of the following criteria at the time of randomization:

  • Histologically confirmed, unresectable, Stage IV metastatic melanoma (AJCC staging), with at least one measurable lesion defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³ 10 mm with spiral computed tomography (CT) scan;
  • Adult men and women of at least 18 years of age at the time of randomization;
  • Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), condom, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) at the time the informed consent is signed, and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522;
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;
  • Life expectancy of at least 16 weeks;
  • WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3;
  • Bilirubin ≤ 1.5 mg/dL, aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 times upper limit of normal (ULN), serum creatinine ≤ 1.5 mg/dL, alkaline phosphatase ≤ 3.0 times ULN and prothrombin time (PT)/partial thromboplastin time (PTT) or international normalized ratio (INR) within normal range;
  • Patients who have had prior treatment with adjuvant immunotherapy are eligible for study randomization provided that therapy ended at least 4 weeks prior to randomization;
  • Patients who had prior surgery are eligible if at least 4 weeks have passed since their surgery;
  • All toxicities related to prior adjuvant therapy must have resolved and all surgical wounds must have healed;
  • Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.

Exclusion

Patients must have none of the following at the time of randomization:

  • Pregnancy or nursing;
  • Prior therapy for metastatic melanoma including chemotherapy, radiotherapy, hormonal therapy, or biologics;
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer;
  • Current or planned participation (from the day of randomization through 30 days after the last dose of MEDI-522) in a research protocol in which an investigational agent or therapy may be administered;
  • Received an investigational agent within 4 weeks prior to randomization;
  • Known brain metastases or primary brain tumors, ocular melanoma, symptomatic pleural effusion or ascites requiring paracentesis;
  • History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer;
  • History of pulmonary embolus.
  • Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (i.e., warfarin or heparin).
  • Currently requiring therapeutic anticoagulation.
  • Any evidence of hematemesis, melena, hematochezia, or gross hematuria;
  • History or presence of bleeding diatheses;
  • Elective surgery planned during the study period through 30 days after the last dose of MEDI-522.
  • History of hypersensitivity to a previously administered monoclonal antibody.
  • History of hypersensitivity to DTIC;
  • History of immunodeficiency;
  • Known human immunodeficiency virus (HIV) or known active viral hepatic infections;
  • A prior myocardial infarction or angina, or uncontrolled/refractory hypertension within 6 months prior to randomization;
  • A prior stroke or transient ischemic attack within the past 6 months;
  • An active infection requiring systemic antiinfective therapy;
  • Prior treatment with MEDI-522 or MEDI-523;
  • A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
  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: NCT00066196

  Show 25 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Luz Hammershaimb, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: Luz Hammershaimb, M.D., V.P., Clinical Dev., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00066196     History of Changes
Obsolete Identifiers: NCT00081081
Other Study ID Numbers: MI-CP095
Study First Received: August 5, 2003
Last Updated: January 14, 2008
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

ClinicalTrials.gov processed this record on October 01, 2014