NCT00019968

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor necrosis factor is more effective than melphalan alone for soft tissue sarcoma. PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have soft tissue sarcoma of the arm or leg.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1999

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 2, 2007

Last Update Submit

October 27, 2023

Conditions

Stage IVB Adult Soft Tissue SarcomaStage IIB Adult Soft Tissue SarcomaStage IIC Adult Soft Tissue SarcomaRecurrent Adult Soft Tissue SarcomaStage IVA Adult Soft Tissue SarcomaStage III Adult Soft Tissue Sarcoma

Keywords

adult soft tissue sarcomaadult solid tumorbody system/site cancercancermuscle cancermusculoskeletal cancerrecurrent adult soft tissue sarcomasolid tumorstage IA, IB, and IIA adult soft tissue sarcomastage II adult soft tissue sarcomastage IIB adult soft tissue sarcomastage IIB, IIC, and III adult soft tissue sarcomastage IIC adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomastage IVA adult soft tissue sarcomastage IVB adult soft tissue sarcomastage, adult soft tissue sarcoma

Interventions

melphalanDRUG
tumor necrosis factorDRUG

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically proven unresectable high grade soft tissue sarcoma of the extremity Measurable disease All disease must be distal to the apex of the femoral triangle in the lower limb and distal to the deltoid insertion in the upper limb Must have no local resection option according to the consensus of staff surgeons and require amputation or resection of major nerves or vascular structures to control disease Metastatic disease allowed if patient would benefit from palliative treatment of primary tumor No prior limb perfusion No newly diagnosed pediatric sarcomas that have curative potential with other chemotherapeutic regimens (i.e., newly diagnosed Ewing's sarcoma, rhabdomyosarcoma, etc.) --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior biologic therapy and recovered Chemotherapy: No prior melphalan At least 1 month since other prior chemotherapy and recovered No more than 1 prior systemic chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent immunosuppressive drugs or chronic anticoagulants that cannot be temporarily discontinued --Patient Characteristics-- Age: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Coagulation studies within 1 second of normal Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe peripheral vascular disease (no prior claudication or other ischemic peripheral vascular manifestations) Other: Weight greater than 30 kg Not pregnant or nursing Negative pregnancy test No active infection HIV negative

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

Sponsors & Collaborators

MeSH Terms

Conditions

SarcomaNeoplasmsMuscle Neoplasms

Interventions

MelphalanTumor Necrosis Factor-alpha

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSoft Tissue NeoplasmsNeoplasms by SiteMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsGlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesTumor Necrosis FactorsBlood ProteinsProteinsBiological Factors

Study Officials

  • H. Richard Alexander, Jr.

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

August 1, 1999

Study Completion

March 1, 2002

Last Updated

October 31, 2023

Record last verified: 2012-03