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

Brief Title

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

Official Title

Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment

Condition

Brain and Central Nervous System Tumors

Intervention

arsenic trioxide

Study Arms / Comparison Groups

 Arsenic Trioxide

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

22

Start Date

March 2001

Completion Date

May 2009

Primary Completion Date

May 2009

Eligibility 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
      

Gender

All

Ages

N/A - 40 Years

Accepts Healthy Volunteers

No

Contacts

Brian H. Kushner, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00024258

Organization ID

01-042

Secondary IDs

P30CA008748

Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Brian H. Kushner, MD, Study Chair, Memorial Sloan Kettering Cancer Center

Verification Date

October 2015