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Status:

WITHDRAWN

A Phase I Trial of Normothermic Isolated Limb Infusion (ILI) With Melphalan Plus Buthionine Sulfoximine (BSO) in Patients With Locally Advanced Malignant Melanoma

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Buthionine sulfoximine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to st...

Detailed Description

OBJECTIVES: Primary * To determine the maximum tolerated dose of melphalan when administered as an isolated limb infusion in combination with a systemic infusion of buthionine sulfoximine (BSO) in p...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically proven primary or recurrent in-transit melanoma of the extremity
  • Stage IIIB or IIIC disease, as determined by whole body imaging with a CT scan of the chest, abdomen, and pelvis AND PET scan within the past 4 weeks
  • Patients with stage IIIC disease must have undergone removal of regional lymph nodes
  • Patients with indeterminate staging must be reviewed by the study chairs prior to study registration
  • Previously treated with melphalan-based regional therapy and had persistent disease at 3 months OR achieved a complete response but disease recurred within 6 months
  • Disease to be treated by regional therapy must be distal to the planned site of tourniquet placement
  • Bidimensionally measurable disease by caliper or a radiological method as defined by the RECIST criteria modified for cutaneous lesions
  • Photo documentation required
  • Patients with a single lesion must have archived tumor tissue available for study analysis
  • No history of tumors with clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within the past 12 weeks
  • No stage IV disease
  • No cerebral metastases
  • PATIENT CHARACTERISTICS:
  • ECOG/Zubrod performance status 0-1
  • Serum creatinine ≤ 1.5 mg/dL
  • WBC ≥ 3,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times normal
  • Must have a palpable femoral/axillary pulse in the affected extremity
  • No uncontrolled seizures or clinically significant CNS disorders
  • No psychiatric condition or diminished capacity that could preclude study compliance or giving informed consent
  • No history of allergic reactions and/or hypersensitivity to melphalan
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of other malignancies except adequately treated basal cell or squamous cell carcinoma of the skin; curatively treated carcinoma in situ of the uterine cervix, prostate cancer, or superficial bladder cancer; or other curatively treated solid tumors with no evidence of disease for ≥ 5 years
  • No stroke or other major tissue injury within the past 4 weeks
  • No other uncontrolled serious chronic disease or condition that, in the investigator's opinion, could preclude study compliance or follow-up
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • More than 4 weeks since prior major surgery
  • Wound healing adequate since last major surgery
  • More than 4 weeks since prior antineoplastic therapy, radiotherapy, or any other investigational drug
  • More than 7 days since prior antimicrobial agents (i.e., antibiotic, antifungal, or antiviral agents) for active infection or infectious symptoms
  • No drugs that are known to cause enhanced glutathione depletion (e.g., acetaminophen) for 7 days before, during, and for 7 days after buthionine sulfoximine (BSO) administration
  • No cephalosporin antibiotics for 7 days before, during, and for 7 days after BSO administration

Exclusion

    Key Trial Info

    Start Date :

    April 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00661336

    Start Date

    April 1 2008

    Last Update

    March 13 2015

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710

    2

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009