search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring metastatic osteosarcoma, recurrent childhood rhabdomyosarcoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, childhood hepatoblastoma, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors, intraocular retinoblastoma, extraocular retinoblastoma, recurrent retinoblastoma, recurrent osteosarcoma, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, localized unresectable neuroblastoma, previously untreated childhood rhabdomyosarcoma, childhood desmoplastic small round cell tumor, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood teratoma, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor

Eligibility Criteria

undefined - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arsenic Trioxide

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
October 22, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00024258
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma
Keywords
metastatic osteosarcoma, recurrent childhood rhabdomyosarcoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, childhood hepatoblastoma, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors, intraocular retinoblastoma, extraocular retinoblastoma, recurrent retinoblastoma, recurrent osteosarcoma, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, localized unresectable neuroblastoma, previously untreated childhood rhabdomyosarcoma, childhood desmoplastic small round cell tumor, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood teratoma, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arsenic Trioxide
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Primary Outcome Measure Information:
Title
Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian H. Kushner, 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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs