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

NCT00024258 | Completed Phase 2 Results

• 5 other identifiers: 01-042P30CA008748MSKCC-01042CTI-1059NCI-G01-2014
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  1 year

Study Arms (1)

Arsenic Trioxide

EXPERIMENTAL

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.

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Arsenic Trioxide

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Kidney Neoplasms; Liver Neoplasms; Neuroblastoma; Ovarian Neoplasms; Retinoblastoma; Sarcoma; Osteosarcoma; Hepatoblastoma; Wilms Tumor; Desmoplastic Small Round Cell Tumor; Medulloblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Teratoma; Testicular Neoplasms; Ovarian Germ Cell Cancer

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Brian Kushner
• Organization: Memorial Sloan Kettering Cancer Center

kushnerb@mskcc.org

212-639-6793

Study Officials

• Brian H. Kushner, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 25, 2015
• Results First Posted: November 25, 2015

Record last verified: 2015-10

Locations

US (1)