Docetaxel in Treating Children With Recurrent Solid Tumors

Recruiting at35 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Research Team

Theodore Zwerdling, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

Inclusion Criteria

Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas

Brain tumors: Ependymoma Primitive neuroectodermal tumor (PNET), High grade astrocytoma, Brain stem glioma (histologic verification not required), Neuroblastoma

Measurable disease that can be followed clinically or radiologically required

Treatment Details

Interventions

• Docetaxel (Taxane)

Participant Groups

Group I: Arm I Experimental Treatment 2 Interventions

All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.

Docetaxel is already approved in Canada, Japan for the following indications:

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School