Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma

Not Recruiting

Trial ID: NCT00077389

Age - N/A-17 Years Condition - Pediatric Cancer, Liver Cancer Gender - All Accepting Healthy Volunteers - No

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.

Official Title

Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma

Stanford Investigator(s)

Gary Dahl

Eligibility


DISEASE CHARACTERISTICS:

   - Histologically confirmed hepatoblastoma

   - High-risk disease, meeting criteria for at least 1 of the following:

      - Tumor involving all 4 hepatic sections

      - Evidence of abdominal extrahepatic disease

      - Presence of metastases

      - Alpha-fetoprotein < 100 ng/mL at diagnosis

   - Must have had a prior diagnostic biopsy within the past 15 days

   - No recurrent disease

PATIENT CHARACTERISTICS:

Age

   - Under 18

Performance status

   - Not specified

Life expectancy

   - Not specified

Hematopoietic

   - Not specified

Hepatic

   - AST and/or ALT ≤ 3 times normal

Renal

   - Glomerular filtration rate ≥ 60 mL/min

Cardiovascular

   - Shortening fraction ≥ 29% OR

   - Ejection fraction ≥ 40%

Other

   - Not pregnant

   - Negative pregnancy test

   - No pre-existing clinically relevant bilateral hearing loss

   - No other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

   - Not specified

Chemotherapy

   - No prior chemotherapy

Endocrine therapy

   - Not specified

Radiotherapy

   - Not specified

Surgery

   - Not specified

Other

   - No prior therapy for hepatoblastoma

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Intervention(s):

drug: carboplatin

drug: cisplatin

drug: doxorubicin hydrochloride

procedure: adjuvant therapy

procedure: conventional surgery

procedure: neoadjuvant therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535

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