Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Amgen; Baxter Healthcare Corporation; Nexell Therapeutics Inc
• Treatments: Carboplatin; Cyclophosphamide; Etoposide; Etoposide phosphate

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven malignant solid tumor, including any of the following:

• Rhabdomyosarcoma

• Neuroblastoma

• Ewing's sarcoma/primitive neuroectodermal tumor

• Germ cell tumors

• Childhood brain tumors

• Hepatoblastoma

• Metastatic disease OR has failed at least first-line therapy

• Ineligible for higher priority protocols

PATIENT CHARACTERISTICS:

Age:

• Under 36 at transplantation

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm3

• Platelet count at least 75,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Liver function tests no greater than 2 times normal OR

• No active hepatitis on liver biopsy

• No hepatitis B infection

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Glomerular filtration rate (preferably measured) greater than 60% of normal

Cardiovascular:

• Left ventricular ejection fraction at least 45%

• No active congestive heart failure

• No active arrhythmia

Pulmonary:

• Age 8 and under: clinically normal pulmonary function

• Over age 8: FEV1 and FVC at least 50% predicted

• Arterial blood gases normal and DLCO at least 50% if spirograms difficult to

• interpret due to poor patient effort, recent surgery, or pulmonary tumor

• involvement

Other:

• No mucositis or mucosal infection prior to myeloablative chemotherapy

• HIV negative

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics