CompletedPhase 2

Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer

United States11 participantsStarted 1993-02

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 autologous bone marrow transplantation may help the body kill more tumor cells. PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.

Who can participate

Age range

18 Years – 120 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 confirmed, measurable germ cell cancer relapsed or refractory after frontline therapy with cisplatin and etoposide-containing chemotherapy * Other chemotherapy-sensitive solid tumors eligible (as of 06/11/97) * Possibility of residual mass representing benign teratoma must be excluded * Elevated serum tumor markers only are acceptable if possibilities of false-positive serum tumor markers or sanctuary disease have been excluded * Also eligible after two to four cycles of conventional dose salvage chemotherapy, regardless of response * No CNS or bone marrow involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 2 months Hematopoietic: * Platelet count at least 100,000/mm3 * Neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of normal, unless due to disease Renal: * Creatinine less than 1.5 times upper limit of normal * Creatinine clearance at least 60 ml/min Cardiovascular: * Ventricular ejection fraction at least 45% * No uncontrolled or severe cardiovascular disease including recent myocardial infarction, congestive heart failure, angina, life-threatening arrhythmia, or hypertension Pulmonary: * DLCO and spirometry greater than 50% of predicted Other: * Not HIV positive * No active peptic ulcer * No uncontrolled diabetes mellitus * No active infection * No previous or c…

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

To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation

Timeframe: 45 days

Trial details

NCT IDNCT00002943

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2003-10

View on ClinicalTrials.gov More Extragonadal Germ Cell Tumor trials