Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma

NCT00017069 | Terminated Phase 2

• 4 other identifiers: CTI-1060CDR0000068646MSKCC-01012NCI-G01-1951
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Interventions

arsenic trioxide DRUG

dexamethasone DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of stage II or III multiple myeloma * Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy * No more than 3 prior cytotoxic regimens * No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation * History of disease progression after prior steroid antimyeloma therapy * No smoldering myeloma * Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Absolute granulocyte count greater than 1,200/mm\^3\* * Platelet count greater than 75,000/mm\^3\* * Hemoglobin greater than 10 g/dL\* NOTE: \*Unless due to multiple myeloma Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels * No significant underlying cardiac dysfunction * No conduction defects * No unstable angina * No congestive heart failure * No New York Heart Association class II-IV cardiac disease * No myocardial infarction within the past 6 months Other: * No preexisting grade 2 or greater neurotoxicity/neuropathy * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No uncontrolled diabetes mellitus * No active serious infection uncontrolled by antibiotics * No history of grand mal seizures (other than infantile febrile seizures) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * See Chemotherapy * At least 28 days since prior biologic therapy Chemotherapy: * See Disease Characteristics * At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation * No other concurrent cytotoxic chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 28 days since prior radiotherapy except for focal radiation for symptom control Surgery: * Not specified

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

Sponsors & Collaborators

• CTI BioPharma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Highlands Oncology Group - Springdale

Springdale, Arkansas, 72764, United States

Location

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868-3849, United States

Location

Stockton Hematology Oncology Medical Group

Stockton, California, 95204, United States

Location

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, 80218, United States

Location

Pasco Pinellas Cancer Center - Tarpon Springs

Tarpon Springs, Florida, 34689, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Mountain States Tumor Institute - Boise

Meridian, Idaho, 83642, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Texas Cancer Care

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Arsenic Trioxide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Scott C. Stromatt, MD

  CTI BioPharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (10)