Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

NCT00003737 | Completed Phase 2

• 3 other identifiers: 98-095CDR0000066852NCI-T98-0041
• Study Type: interventional
• Target: 30
• 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 II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma

Outcome Measures

Primary Outcomes (3)

• Response (complete response, very good partial response, or partial response)

• Freedom from progression

• Time to treatment failure

Secondary Outcomes (1)

• Toxicity

Interventions

becatecarin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven relapsed or refractory neuroblastoma * Measurable disease PATIENT CHARACTERISTICS: Age: * Children Performance status: * ECOG 0-2 Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT and SGPT less than 2.5 times upper limit of normal (ULN) * Adequate liver function unless due to disease Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min * Adequate renal function unless due to disease Other: * No other serious concurrent illness * No active uncontrolled infection * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy * Prior autologous bone marrow transplantation allowed * No concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No other concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Recovered from prior radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

becatecarin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tanya Trippett, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1999
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)