Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer

NCT00030082 | Completed Phase 1

• 2 other identifiers: CDR0000068941NCI-01-C-0215
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.

Conditions

Liver Cancer; Metastatic Cancer

Keywords

localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; liver metastases

Interventions

isolated perfusion DRUG

melphalan DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable cancer of the parenchyma of the liver * Liver metastases allowed * Limited unresectable extrahepatic disease (including but not limited to the following) is allowed provided the life-threatening component of progressive disease is in liver: * Up to 4 pulmonary nodules each less than 1 cm in diameter * Retroperitoneal lymph nodes less than 3 cm in diameter * Fewer than 10 skin or subcutaneous metastases less than 1 cm in diameter * Asymptomatic bone metastases that have been or can be palliated with radiotherapy * Solitary metastasis to any site that can be resected * Prior therapy with intrahepatic perfusion with or without hepatic arterial infusion with floxuridine is allowed provided patient had a radiographic partial response of 3-months duration PATIENT CHARACTERISTICS: Age: * 14 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count at least 1,300/mm\^3 * Hematocrit greater than 27% Hepatic: * Bilirubin no greater than 2.0 mg/dL * PT within 2 seconds of upper limit of normal * No biopsy-proven cirrhosis with evidence of portal hypertension by history, endoscopy, or radiologic study Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No prior congestive heart failure with LVEF less than 40% Pulmonary: * No chronic obstructive pulmonary disease * No other chronic pulmonary disease * FEV\_1 at least 30% of predicted * DLCO at least 40% of predicted Other: * Weight greater than 35 kg * HIV negative * No active infections * No severe allergic reaction to iodine contrast not controlled by antihistamines or steroids * No known prior hypersensitivity reaction to melphalan * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior biologic therapy for the malignancy and recovered Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy for the malignancy and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 1 month since prior radiotherapy for the malignancy and recovered Surgery: * Not specified Other: * No concurrent chronic anticoagulants * No concurrent immunosuppressive drugs

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis; Carcinoma, Hepatocellular

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

• H. Richard Alexander, MD, FACS

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 30, 2002
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Last Updated: April 30, 2015

Record last verified: 2004-07

Locations

US (1)