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

NCT02507076 | Withdrawn DMC

• 4 other identifiers: 11-12-411NCI-2013-0121811-103P30CA013330
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete and partial response) assessed by the RECIST v1.1

  Rates of complete and partial response will be computed and reported with their 95% confidence intervals.

  Up to 12 weeks

Secondary Outcomes (3)

• Time to recurrence

  Up to 4 years

• Progression-free survival

  Time of ILP procedure to date of recurrence, assessed up to 4 years

• Overall survival

  Time of ILP treatment to time of death, assessed up to 4 years

Study Arms (1)

Treatment (ILP with melphalan)

EXPERIMENTAL

Patients undergo ILP with melphalan IV over 60 minutes.

Drug: isolated limb perfusion; Drug: melphalan; Procedure: quality-of-life assessment

Interventions

isolated limb perfusion DRUG

Undergo ILP with melphalan

Also known as: isolated limb infusion

Treatment (ILP with melphalan)

melphalan DRUG

Undergo ILP with melphalan

Also known as: Alkeran, CB-3025, L-PAM, L-phenylalanine mustard, L-Sarcolysin

Treatment (ILP with melphalan)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (ILP with melphalan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Sarcoma; Melanoma; Skin Neoplasms

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Connective and Soft Tissue; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Katia Papalezova

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: April 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

US (1)