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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017069
First received: June 6, 2001
Last updated: November 16, 2008
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: arsenic trioxide
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
  • Determine the rates of overall and relapse-free survival in patients treated with this regimen.
  • Determine the safety profile of this treatment regimen in these patients.

OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.

Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017069

Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
Stockton Hematology Oncology Medical Group
Stockton, California, United States, 95204
United States, Colorado
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States, 80218
United States, Florida
Pasco Pinellas Cancer Center - Tarpon Springs
Tarpon Springs, Florida, United States, 34689
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Idaho
Mountain States Tumor Institute - Boise
Meridian, Idaho, United States, 83642
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
Texas Cancer Care
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Chair: Scott C. Stromatt, MD CTI BioPharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00017069     History of Changes
Other Study ID Numbers: CDR0000068646, CTI-1060, MSKCC-01012, NCI-G01-1951
Study First Received: June 6, 2001
Last Updated: November 16, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Arsenic trioxide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on October 19, 2014