Know Cancer

or
forgot password

A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver


Phase 2
N/A
N/A
Not Enrolling
Both
Colorectal Cancer, Islet Cell Tumor, Liver Cancer, Metastatic Cancer, Neuroendocrine Carcinoma

Thank you

Trial Information

A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver


OBJECTIVES:

- Determine response rate, duration of response, and patterns of recurrence in patients
with primary or metastatic, unresectable cancers of the liver after treatment with
isolated hepatic perfusion with melphalan.

- Determine the disease-free and overall survival of patients treated with this regimen.

OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the
peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases,
or unresectable pathologically-involved lymph nodes outside area of portahepatis do not
receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan.
Liver perfusion proceeds for 1 hour.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until
disease progression.

PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven liver cancer meeting 1 of the following
criteria:

- Primary unresectable hepatocellular or cholangiocellular carcinoma

- Metastatic cancer to the liver originating from one of the following:

- Intraocular melanoma (closed to accrual as of 10/17/03)

- Islet cell carcinoma

- Adenocarcinoma of the colon or rectum limited to parenchyma of the liver

- No evidence of other unresectable extrahepatic colorectal metastasis

- Other neuroendocrine tumors, such as carcinoid tumors

- Measurable disease

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count greater than 100,000/mm^3

- Hematocrit greater than 27.0%

- WBC at least 2,500/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)

- PT no greater than 2 seconds above upper limit of normal

- Elevated SGOT and SGPT allowed if not due to hepatitis

- No biopsy-proven cirrhosis or evidence of significant portal hypertension

- No prior or concurrent veno-occlusive disease

- Patients with positive hepatitis B or C surface antigen serology and chronic active
hepatitis are eligible provided there is no evidence of cirrhosis

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- Congestive heart failure allowed if LVEF ≥ 40%

Pulmonary:

- No chronic obstructive pulmonary disease or other chronic pulmonary disease with
pulmonary function tests less than 50% predicted for age

Other:

- Weight greater than 30 kg

- Not pregnant or nursing

- Negative pregnancy test

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 month since prior anticancer biologic therapy and recovered

Chemotherapy:

- At least 1 month since prior anticancer chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 1 month since prior anticancer radiotherapy and recovered

Surgery:

- Not specified

Other:

- Prior intrahepatic arterial infusion therapy allowed

- No chronic use of anticoagulants

- No concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

H. Richard Alexander, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

990123

NCT ID:

NCT00019786

Start Date:

August 1999

Completion Date:

January 2006

Related Keywords:

  • Colorectal Cancer
  • Islet Cell Tumor
  • Liver Cancer
  • Metastatic Cancer
  • Neuroendocrine Carcinoma
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • recurrent islet cell carcinoma
  • adult primary hepatocellular carcinoma
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • adult primary cholangiocellular carcinoma
  • advanced adult primary liver cancer
  • recurrent childhood liver cancer
  • childhood hepatocellular carcinoma
  • stage III childhood liver cancer
  • stage IV childhood liver cancer
  • neuroendocrine carcinoma
  • Carcinoma
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Carcinoma, Neuroendocrine
  • Adenoma, Islet Cell

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182