NCT00004250

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy to the tumor area only may kill more tumor cells and cause less damage to healthy tissues. PURPOSE: This phase II trial is studying isolated limb infusion of chemotherapy to see how well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg that cannot be removed by surgery.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

7.8 years

First QC Date

January 28, 2000

Last Update Submit

January 15, 2013

Conditions

Melanoma (Skin)Sarcoma

Keywords

stage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage III melanomastage IV melanomarecurrent melanomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (3)

  • Efficacy

  • Morbidity

  • Expression of melanoma-associated antigens

Interventions

dactinomycinBIOLOGICAL
isolated limb perfusionDRUG
melphalanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection * Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb * Bidimensionally measurable disease in the extremity * Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 6 months Hematopoietic: * WBC at least 3,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * Must have palpable femoral/axillary, dorsalis pedis/popliteal, or radial pulses in the extremity to be treated * No signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease) Other: * Not pregnant or nursing * Negative pregnancy test * No other concurrent serious illness * No severe diabetes * No prior extremity complications due to diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior antitumor therapy and recovered * At least 2 weeks since prior antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Brady MS, Brown K, Patel A, Fisher C, Marx W. Isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft-tissue sarcoma of the extremity: final report of a phase II clinical trial. Melanoma Res. 2009 Apr;19(2):106-11. doi: 10.1097/CMR.0b013e32832985e3.

    PMID: 19282789RESULT

MeSH Terms

Conditions

MelanomaSarcoma

Interventions

DactinomycinMelphalan

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Mary S. Brady, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

June 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)