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


Phase 2
N/A
18 Years
Not Enrolling
Both
Neuroblastoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Tanya Trippett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-095

NCT ID:

NCT00003737

Start Date:

January 1999

Completion Date:

September 2006

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021