CompletedPhase 1

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors

United States, Australia, Canada94 participantsStarted 1998-03

Plain-language summary

RATIONALE: 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 doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically proven malignant brain or spinal cord tumor, including the following: * Primitive neuroectodermal tumor * Ganglioneuroblastoma * Medulloblastoma neuroblastoma * Desmoplastic medulloblastoma * Medulloepithelioma * Ependymoma neuroepithelioma * Anaplastic ependymoma germ cell tumor * Astrocytoma germinoma * Anaplastic astrocytoma * Embryonal carcinoma * Glioblastoma endodermal sinus tumor * Gliosarcoma malignant teratoma * Choroid plexus carcinoma * Mixed germ cell tumor * Cerebellar sarcoma * Pineoblastoma * Atypical teratoid/rhabdoid tumor * Choriocarcinoma * Teratoma (malignant or with malignant transformations) * Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 6 months to less than 3 years Performance Status: * Not specified Life Expectancy: * More than 8 weeks Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Glomerular filtration rate or creatinine clearance greater than 70 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior corticosteroids allowed Radiotherapy: * No prior radiotherapy Surgery: * No more than 6 weeks since prior surgery * Recovered from prior surgery (stable)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility

Timeframe: Up to 4 weeks after completion of study treatment

Maximal tolerated dose of thiotepa for consolidation therapy

Timeframe: 9 weeks

Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV)

Timeframe: Up to 6 years

Trial details

NCT IDNCT00003141

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2007-12

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