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| Sponsor: | Pediatric Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003370 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irofulven in treating children with recurrent or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: irofulven |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study |
| Study Start Date: | August 1998 |
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene (MGI-114) in pediatric patients with recurrent or refractory solid tumors. II. Determine the incidence and severity of other toxic effects of MGI-114. III. Determine a safe and tolerable dose of MGI-114 to be used in phase II studies. IV. Determine the pharmacokinetics of MGI-114 in these patients. V. Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors.
OUTLINE: This is a dose escalation study. If the dose limiting toxicity is myelosuppression in stratum 1, then stratum 1 is closed and stratum 2 opens. Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy regimens; patients who have not received prior central axis radiation or bone marrow transplantation; and patients with no known bone marrow involvement. Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed. Patients with stable or responding disease may receive up to 1 year of therapy. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy. Patients are followed until death.
PROJECTED ACCRUAL: Approximately 12 patients will be accrued per year.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven recurrent or refractory solid tumors No leukemia Patients with brain tumors are not eligible until the first 2 patients at each dose level are evaluable for toxicity
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 50-100% Lansky play scale 50-100% (for infants) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 5 times upper limit of normal Renal: Creatinine normal for age OR GFR at least 70 mL/min Cardiovascular: Cardiac shortening fraction at least 27% OR institutional normal OR Cardiac ejection fraction greater than 50% OR institutional normal Neurologic: Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after the study No uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior growth factor therapy and recovered At least 6 months since prior bone marrow transplantation and no evidence of graft versus host disease Chemotherapy: At least 2 weeks since prior myelosuppressive chemotherapy and recovered At least 6 weeks since prior nitrosourea and recovered At least 2 weeks on stable dexamethasone for patients with CNS tumors No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy: At least 2 weeks since prior palliative radiotherapy (small port) At least 6 months since prior substantial bone marrow radiation At least 6 months since total abdominal, pelvic, chest, mantle, and Y ports radiotherapy Surgery: Not specified Other: No other concurrent anticancer therapy or investigational agents
Contacts and Locations
Show 56 Study Locations| Study Chair: | Gail C. Megason, MD | University of Mississippi Cancer Clinic |
More Information
| Study ID Numbers: | CDR0000066359, POG-9772 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003370 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific |
|
Neoplasms Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Irofulven Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |