Clinical trial · Interventional
Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression
NCT00006006CI-TRIAL-00009401completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.
- interventionNames
- Biological: recombinant interferon alfa
- Drug: thalidomide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hepatocellular carcinoma OR * Diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis B or C * Measurable disease * At least 20 mm in one dimension * Not amenable to curative surgical resection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Hematopoietic: * Absolute neutrophil count greater than 1,200/mm\^3 * Hemoglobin at least 8.0 mg/dL * Platelet count at least 25,000/mm\^3 Hepatic: * Bilirubin no greater than 5 mg/dL * Liver function tests no greater than 5 times normal Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Regardless of fertility status: * All women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study * All men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study * No other medical condition that would preclude study * No other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic therapy regimen * No prior interferon or thalidomide for hepatocellular cancer Chemotherapy: * No more than 1 prior chemotherapy regimen Other: * No concurrent barbiturates or alcohol
References
Publications (1)
- RESULTSchwartz JD, Sung M, Schwartz M, Lehrer D, Mandeli J, Liebes L, Goldenberg A, Volm M. Thalidomide in advanced hepatocellular carcinoma with optional low-dose interferon-alpha2a upon progression. Oncologist. 2005 Oct;10(9):718-27. doi: 10.1634/theoncologist.10-9-718. PMID 16249352