Irinotecan in Treating Children With Refractory or Progressive Solid Tumors

NCT00016861 | Completed Phase 1

• 4 other identifiers: TCCC-H-6957CDR0000068568TCCC-GCRC-0654NCI-V01-1654
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressive solid tumors.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Interventions

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists * Brain tumors eligible * Histologic verification waived for brain stem gliomas * Evaluable disease * No bone marrow involvement PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * Karnofsky 50-100% (over age 10) * Lansky 50-100% (age 10 and under) Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * SGPT less than 5 times normal Renal: * Creatinine normal OR * Glomerular filtration rate at least 70 mL/min Other: * No uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy) * At least 1 week since prior growth factors * No prior BMT with total body irradiation (stratum I) * No prior BMT with or without total body irradiation (stratum 2) * No prior allogeneic BMT (all strata) * No concurrent sargramostim (GM-CSF) * No other concurrent prophylactic growth factor support during the first course of therapy Chemotherapy: * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * No prior irinotecan * No more than 2 prior multi-agent chemotherapy regimens (stratum 2) * No other concurrent chemotherapy Endocrine therapy: * Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study Radiotherapy: * At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2) Surgery: * Not specified Other: * Recovered from all prior therapy * No other concurrent investigational agents * Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3) * Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Texas Children's Cancer Center: lead

Study Sites (1)

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

MeSH Terms

Interventions

Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Susan M. Blaney, MD

  Texas Children's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 1998
• Study Completion: January 1, 2005
• Last Updated: June 26, 2013

Record last verified: 2004-11

Locations

US (1)