CompletedPhase 1

Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors

United States14 participantsStarted 2012-10-26

Plain-language summary

The purpose of this research study is to determine whether taking either of two low dose drugs that would prevent new blood vessels from growing after stem cell transplant is feasible, and what the side effects of taking each of these drugs after autologous transplant might be. The reason the investigators are looking at these drugs is because one of the things that allows tumors to grow quickly is their ability to stimulate the growth of new blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the investigators hope to prevent the tumors from coming back or continuing to grow.

Who can participate

Age range6 Months – 21 Years

SexALL

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Inclusion criteria

✓. If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMSTM Program prior to day +30 post-ASCR.
✓. If enrolled in Arm III of this study, patient must be willing to practice birth control as outlined in the THALOMID REMSTM Program from the beginning of the thalidomide treatment until at least 4 weeks following discontinuation of thalidomide therapy. Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is chosen. Contraceptive methods must include at least one highly effective method (e.g. oral contraceptive pills, injections, hormonal patches, IUD, or implants), AND one additional effective barrier method (e.g. latex condom, diaphragm, cervical cap).
✓. Pregnancy surveillance:

What they're measuring

Safety as measured by absence of grade 4 or 5 non-hematological or grade 5 hematological toxicity

Timeframe: Through 1 year post-transplant

Incidence of major transplant related toxicities (Grades IV and IV)

Timeframe: Within the first year of transplant

Trial details

NCT IDNCT01661400

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-27

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