Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma
Conditions
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
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.
Interventions
DRUGarsenic trioxide
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease Progression | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Arsenic Trioxide |
|---|---|
| Age, Categorical <=18 years | 19 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 22 |
| serious Total, serious adverse events | 12 / 22 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arsenic Trioxide | Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment | Progression of Disease | 16 participants |
| Arsenic Trioxide | Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment | Stable Disease | 5 participants |