Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Neuroblastoma

Treatments: Drug: becatecarin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003737

98-095

NCI-T98-0041

CDR0000066852 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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