Search / Trial NCT00001577

Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Chemotherapy Hyperthermia Isolation Perfusion Regional Therapy

Description

Patients with extremity melanoma (Stage IIIA, IIIAB or Stage IV disease who have bulky symptomatic tumor located in the extremity) or patients with unresectable extremity sarcoma will undergo a double isolated limb perfusion with melphalan alone separated by approximately 4 to 6 weeks. The initial perfusion will be done with a melphalan dose of 6 mg/L limb volume and the interval perfusion with a dose of 9 mg/L limb volume. For patients with extremity sarcoma the tumor will be excised if feasible using a limb sparing resection between 6-12 weeks after the second perfusion. Technical feasibi...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed unresectable sarcoma or intransit melanoma of the upper or lower extremity.
  • Extremity sarcoma with no local resection option and would require amputation based upon abutment or proximity of the tumor to major neurovascular structures or bone or joint structures.
  • MELANOMA PATIENTS:
  • Must have history of two or more satellite intransit metastases of which one may be excised for diagnosis with the exception of patients with a single, large, deep, locally recurrent tumor or metastatic tumor (greater than 5 cm) that precludes an excision with primary closure. Stage IV melanoma must have a significant component (greater than 90%) of disease distal to the apex of the femoral triangle in the lower limb or distal to the insertion of the deltoid in the upper limb.
  • Must have evaluable disease in the extremity. Melanoma must have dermal or subcutaneous lesion that can be measure directly in two diameters to assess tumor burden. Sarcoma must have either cutaneous lesions amenable to direct measurement or deeper lesions that can be measured on CT or MRI scans.
  • PRIOR/CONCURRENT THERAPY:
  • At least 2 months since any regional therapy to the affected extremity.
  • BIOLOGIC THERAPY: At least 1 month since Biologic Therapy.
  • CHEMOTHERAPY: At least 1 month since chemotherapy.
  • ENDOCRINE THERAPY: Not specified.
  • RADIOTHERAPY: At least 1 month since radiotherapy.
  • SURGERY: Not specified.
  • PATIENT CHARACTERISTICS:
  • AGE: 18 and over.
  • PERFORMANCE STATUS: ECOG 0-2.
  • LIFE EXPECTANCY: At least 6 months.
  • HEMATOPOIETIC: Platelet count greater than 150,000/mm(3).
  • HEPATIC: Bilirubin less than 2.0 mg/dL.
  • RENAL: Creatinine less than 2.0 mg/dL.
  • CARDIOVASCULAR: No history of congestive heart failure with an LVEF less than 40%.
  • PULMONARY:
  • No chronic obstructive pulmonary disease.
  • No other chronic pulmonary disease with PFTs less than 50% predicted for age.
  • OTHER:
  • IF HIV POSITIVE: Must have CD4 cell count greater than 500/mL and, No clinical manifestations of AIDS. Coagulation parameters no greater than 1-2 seconds within the upper limit of normal.
  • No evidence of severe peripheral vascular disease.
  • No history of claudication or other ischemic vascular disease.
  • Not pregnant or nursing.

Attachments

readout_NCT00001577_2023-12-10.pdf

4.5 MB

NCT00001577_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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3 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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