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Isolated Limb Perfusion With Melphalan in Treating Patients With Stage IIIB-IV Melanoma or Sarcoma

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ClinicalTrials.gov Identifier: NCT02507076
Recruitment Status : Withdrawn (no enrollment)
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Albert Einstein College of Medicine

Brief Summary:
This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the arteries around the tumor may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma of the Skin Eccrine Carcinoma of the Skin Recurrent Adult Soft Tissue Sarcoma Recurrent Melanoma Recurrent Skin Cancer Squamous Cell Carcinoma of the Skin Stage III Adult Soft Tissue Sarcoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Adult Soft Tissue Sarcoma Stage IV Melanoma Drug: isolated limb perfusion Drug: melphalan Procedure: quality-of-life assessment Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. This prospective trial will evaluate total response rate, including complete and partial response, in patients with unresectable extremity melanoma (or other skin cancer including but not limited to Merkel cell carcinoma) or soft tissue sarcoma treated with hyperthermic-isolated limb perfusion (ILP) with melphalan.

SECONDARY OBJECTIVES:

I. To evaluate the technical parameters including achievement of regional hyperthermia, arterial blood gas (ABG), tourniquet time, and their association with tumor response.

II. To evaluate time to recurrence and progression free survival (PFS) for patients with advanced extremity melanoma or sarcoma who achieved complete response after treatment with ILP with melphalan.

III. To evaluate overall survival rate and duration of survival for patients with advanced melanoma or sarcoma limited to extremity undergoing ILP with melphalan.

IV. To assess quality of life (QOL) score for patients undergoing ILP with melphalan.

OUTLINE:

Patients undergo ILP with melphalan intravenously (IV) over 60 minutes.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year, and then periodically thereafter.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isolated Limb Perfusion for Advanced Melanoma or Sarcoma Limited to Extremity With or Without Distant Metastases
Study Start Date : April 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


Arm Intervention/treatment
Experimental: Treatment (ILP with melphalan)
Patients undergo ILP with melphalan IV over 60 minutes.
Drug: isolated limb perfusion
Undergo ILP with melphalan
Other Name: isolated limb infusion

Drug: melphalan
Undergo ILP with melphalan
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  1. Overall response rate (complete and partial response) assessed by the RECIST v1.1 [ Time Frame: Up to 12 weeks ]
    Rates of complete and partial response will be computed and reported with their 95% confidence intervals.


Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: Up to 4 years ]
    Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.

  2. Progression-free survival [ Time Frame: Time of ILP procedure to date of recurrence, assessed up to 4 years ]
    Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.

  3. Overall survival [ Time Frame: Time of ILP treatment to time of death, assessed up to 4 years ]
    Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • The patient must have histological-proven primary or recurrent extremity melanoma (or other skin cancer including but not limited to Merkel cell carcinoma) or sarcoma, stage IIIB, IIIC, or IV (American Joint Committee on Cancer [AJCC] staging must be documented in patient's medical record, as determined by computed tomography [CT] of the chest, abdomen and pelvis, and/or whole body positron emission tomography [PET] scan, within six weeks prior to administration of study drug)
  • Patients with stage IV disease who have high tumor burden and extensive symptomatic extremity disease
  • Patients with stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed either at the time of regional treatment or soon thereafter
  • Disease to be treated by ILP must be unresectable and distal to the planned site of tourniquet placement (which for the leg is generally the apex of the femoral triangle, or for the arm is distal to the deltoid insertion)
  • Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (RECIST updated version 1.1); lesional tissue not necessary for diagnostic or other clinical purposes may be designated prospectively for research tissue banking
  • Hemoglobin >= 8.0 g/dl
  • White blood count (WBC) of >= 2000 m^3
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x the ULN
  • Creatinine =< 1.5 x ULN
  • Patient must have a palpable femoral/radial pulse in the affected extremity
  • Patients must have a life expectancy of > 6 months
  • Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures
  • Patient or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of their protected health information at any institution subject to United States Health Insurance Portability and Accountability Act (US HIPAA) regulations; NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration

Exclusion Criteria:

  • Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
  • Known brain metastasis; patients with neurological symptoms must undergo a CT scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis
  • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Pulmonary hemorrhage/bleeding event >= CTCAE grade 2 within 4 weeks of ILP/isolated limb infusion (ILI); any other hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks ILP/ILI
  • Major surgery or significant traumatic injury within 30 days of ILI/ILP
  • Evidence or history of bleeding diathesis or coagulopathy
  • Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration
  • Patients with symptoms or signs of vascular insufficiency; specifically, patients with any history of blood clots or lifestyle altering ischemic peripheral vascular disease will be excluded
  • History of allergic reactions and/or hypersensitivity to melphalan
  • Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
  • Pregnant or nursing women are not eligible for this study
  • Unable to return at the regular required intervals for reassessment, or study drug administration
  • Patients with known heparin induced thrombocytopenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507076


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Katia Papalezova Albert Einstein College of Medicine

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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02507076     History of Changes
Other Study ID Numbers: 11-12-411
NCI-2013-01218 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-103
11-12-411 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Sarcoma
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs