A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver
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ClinicalTrials.gov Identifier: NCT00001587 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Neoplasms Neoplasm Metastasis | Procedure: Isolated hepatic portal and arterial perfusion Drug: Melphalan | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver |
Study Start Date : | September 1997 |
Study Completion Date : | March 2001 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Histologically or cytologically proven measurable primary or metastatic non-colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies.
Limited resectable extrahepatic disease is acceptable.
Patients with colorectal cancer previously treated with intrahepatic arterial infusional therapy using FUDR, those with aberrant arterial anatomy such that infusional therapy is not possible, or those with limited extrahepatic disease such that regional therapy is not indicated will be eligible for this protocol.
Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.
Patients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment.
Patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a PT and PTT that are within 1-2 seconds of the upper normal limit.
No patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be included.
No patients with a history of congestive heart failure with an LVEF of equal to or less than 40% will be included.
No patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be included.
Patients must be 18 years of age or older.
Patients must have a platelet count greater than 100,000, a HCT greater than 27.0, a white blood count greater than 3000/ micrograms, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.
No pregnant patients or nursing mothers will be eligible.
Patients must not be taking immunosuppressive drugs or on chronic anticoagulation.
Patients must not have an active infection.
Patients with severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids are not eligible as a hepatic angiogram is needed for this procedure.
Patients must not have HIV disease.
Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks.
The patient must be willing to sign an informed consent.
Patients must not have a history of veno occlusive disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001587
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001587 |
Other Study ID Numbers: |
970200 97-C-0200 |
First Posted: | December 10, 2002 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | April 2000 |
Hyperthermia Metastases Organ Perfusion Regional Therapy |
Neoplasms Neoplasm Metastasis Liver Neoplasms Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Melphalan Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |