Administration of High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis of children and adolescents with high risk tumors of the central nervous system and other miscellaneous solid tumors is poor despite modern treatment protocols. Frequently, physicians suggest additional therapy with high dose chemotherapy after a good initial response to standard doses of treatment has been obtained, so as to reduce the chance that the tumor will recur. We propose a regimen of high dose thiotepa and melphalan followed by rescue of the patient's previously stored hematopoietic (blood manufacturing) system with blood stem cells. The aim of this study is to prove that this therapy is tolerable in children and adolescents, that it results in tolerable levels of toxicity, and that it improves the survival of this group of children as compared to standard therapy given in the past

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Melphalan; Thiotepa

Criteria

Inclusion Criteria:

• Age 1-21 years

• CNS tumors, hepatic tumors and other solid tumors that are chemosensitive

• Minimal disease as determined by either radiological studies or biochemical markers (as determined by treating physician).

• Consent of patient or surrogate.

Exclusion Criteria:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known HIV or AIDS infection

• No active bacterial, fungal, or viral infection

• No medical condition that would preclude study treatment

• Positive pregnancy test or failure to use contraceptives.

• Creatinine >1.5 times limit of normal for age

• SGOT or SGPT more than 3 times normal.