Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

NCT ID: NCT00024258

Last Updated: 2015-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2009-05-31

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 arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Detailed Description

OBJECTIVES:

• Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
• Determine the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).

Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 1 year and then annually thereafter.

Conditions

Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arsenic Trioxide

Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 1 year and then annually thereafter.

Group Type: EXPERIMENTAL

arsenic trioxide

Intervention Type: DRUG

Interventions

arsenic trioxide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:

• Ewing's family of tumors/primitive neuroectodermal tumor
• Retinoblastoma
• Nephroblastoma
• Osteosarcoma
• Rhabdomyosarcoma
• Desmoplastic small round-cell tumor
• Hepatoblastoma
• Germ cell tumors
• Medulloblastoma
• Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
• Measurable disease (e.g., solid mass with definable dimensions) OR
• Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)

PATIENT CHARACTERISTICS:

Age:

• 40 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 2.5 times ULN

Cardiovascular:

• Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels

Other:

• No pre-existing neurotoxicity/neuropathy grade 2 or greater
• No pre-existing convulsive disorder
• No active serious infections uncontrolled by antibiotics
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 3 weeks since prior cytotoxic chemotherapy
• No other concurrent cytotoxic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field

Surgery:

• Not specified

Other:

• No other concurrent investigational agents

• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian H. Kushner, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-01042

Identifier Type: -

Identifier Source: secondary_id

CTI-1059

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2014

Identifier Type: -

Identifier Source: secondary_id

01-042

Identifier Type: -

Identifier Source: org_study_id