CompletedPhase 1

Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors

United States95 participantsStarted 2004-02

Plain-language summary

This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.

Who can participate

Age range

21 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.

Inclusion Criteria: * One of the following histologically confirmed solid tumors: * Brain tumors * Osteogenic sarcoma * Rhabdomyosarcoma * Soft tissue sarcoma (excluding Ewing's sarcoma) * Neuroblastoma * Germ cell tumors * Recurrent or refractory disease * No known curative therapy exists * Performance status - Karnofsky 50-100% (for patients age 11 to 21) * Performance status - Lansky 50-100% (for patients age 10 and under) * At least 8 weeks * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 (transfusion independent\*) * Hemoglobin \> 8.0 g/dL (transfusion allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL for patients age 5 and under * ≤ 1.0 mg/dL for patients 6 to 10 * ≤ 1.2 mg/dL for patients 11 to 15 * ≤ 1.5 mg/dL for patients age 15 to 21 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow tablets (for patients in part 2 only) * No uncontrolled infection * Recovered from all prior immunotherapy * At least 7 days since prior biologic therapy * At least 3 months since prior stem cell transplantation and no evidence of active graft-versus-host disease * More than 1 week since prior growth factors * No concurrent prophylactic growth factor therapy * No concurrent immun…

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

Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Timeframe: 56 days (2 courses)

Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0

Timeframe: 56 days (2 courses)

Pharmacokinetics of erlotinib hydrochloride

Timeframe: At baseline and at 0.5, 1, 2, 4, 6, 8, and 24 hours of course 1

Trial details

NCT IDNCT00077454

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2007-09

View on ClinicalTrials.gov More Previously Treated Childhood Rhabdomyosarcoma trials

Plain-language summary

Who can participate

Age range

21 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.

What they're measuring

Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Timeframe: 56 days (2 courses)

Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0

Timeframe: 56 days (2 courses)

Pharmacokinetics of erlotinib hydrochloride

Timeframe: At baseline and at 0.5, 1, 2, 4, 6, 8, and 24 hours of course 1