Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

becatecarin

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

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

Freedom from progression

Time to treatment failure

Secondary Outcome Measures

Toxicity

Full Information

NCT ID

NCT00003737

First Posted

November 1, 1999

Last Updated

June 24, 2013

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003737

Brief Title

Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Official Title

A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

January 1999 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

Detailed Description

OBJECTIVES: Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma. Determine the toxicity of this drug in these patients. Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients. OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroblastoma

Keywords

recurrent neuroblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

becatecarin

Primary Outcome Measure Information:

Title

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

Title

Freedom from progression

Title

Time to treatment failure

Secondary Outcome Measure Information:

Title

Toxicity

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tanya Trippett, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Neuroblastoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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