TerminatedPhase 1

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors

Stopped: Study enrollment did not meet expected goals

United States24 participantsStarted 1997-07

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 doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.

Who can participate

Age range

1 Year – 30 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 recurrent or refractory pediatric solid tumor * Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: * 1 to 30 Performance status: * 0-2 Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 100,000/mm3 (transfusion independent) * Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 2.5 times normal Renal: * Adequate renal function as defined by one of the following: * GFR by creatinine clearance * Radioisotope GFR * Iothalamate at least 70 mL/min Cardiovascular: * Adequate cardiac function as defined by one of the following: * Ejection fraction at least 55% by MUGA * Fractional shortening at least 28% by echocardiogram Neurologic: * Adequate CNS function as defined by: * Seizure disorder, if present, controlled by anticonvulsants * CNS toxicity no greater than grade 2 Other: * No uncontrolled infections * Not pregnant or nursing * No allergy to platinum compounds * No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy * At least 1 week since prior cytokines * At least 3 months since prior bone marrow or peripheral blood stem cell transplantation * No concurrent immunomodulator * No concurrent cytokines Chemotherapy: * At least 3 w…

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.

Trial details

NCT IDNCT00003194

SponsorSeattle Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2002-12-19

View on ClinicalTrials.gov More Unspecified Childhood Solid Tumor, Protocol Specific trials